PrediabetesNCT06656377
Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
A study testing exercise intervention in people with Prediabetes and Exercise, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic. The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance… Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Prediabetes, Exercise, Blood Glucose Profile
- What is being tested?
- exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prediabetic adults between 20-to-35-year age group with and without a family history of diabetes mellitus will be recruited into the study.
- Diagnosis of prediabetes will be made through HbA1c (prediabetic range is 5·7 - 6·4%), and impaired fasting glucose (fasting plasma glucose 5·6 -6·9 mmol/L) -
Who cannot join
- 1. Participants with type 2 diabetes and other diseases, on lipid-lowering drugs, pregnant and lactating females or participating in some other study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Medical University
Peshawar, Khyber Pukhtoon Khwa, 25000
About this study
The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic. The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance adherence in best scientific manner possible.
Read the detailed description
Participants will be selected from Peshawar and the study will be carried in accordance with the ethical code of research as per the revised (2013) declaration of Helsinki 1975. The volunteers will be recruited through posters, banners and personal contacts. The aims, objectives, purpose and procedure of the study will be explained to each participant. A written informed consent from all the participants will be taken after agreement and they will be informed about their right to leave the trial at any time if they don't want.
After selection, the recruited, participants will be asked to attend the lab for 12 visits over 6 months. On the day of experiment, patients will be received in Lab in fasting state, where baseline measurements, weight, age, BMI, W/H ratio, body composition will be determined. They will be screened for exercise fitness through PAR_Q and exercise readiness questionnaire. Detailed history of the patients (Diabetes Mellitus, medications, and economic conditions) and General Physical Examination will be carried out.
This study will be triphasic during which optimal timing of the exercise in post prandial state, optimal intensity of the exercise and optimal duration of the exercise will be quantified. For this a single cohort of 12 participants will be selected with crossover design who will attend the lab 12 times in total for all phases (04 visits for single phase). Each participant will attend the lab 12 times in total during the intervention. Each participant will be provided with one week time as wash out period.
The details of the actual visits of participants to Physiology Skill lab in detail is as under:
TIMING Protocol:
This protocol is aimed to determine the best possible time for exercise execution in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (7 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at different intervals with the following details:
Visit 1:
The participants will perform exercise 30 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).
Visit 2: - The participants will perform exercise 60 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).
Visit 3: - The participants will perform exercise 90 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise 120 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
This protocol will provide us an optimal time for exercise in post prandial state.
Intensity Protocol:
This protocol is aimed to determine the best possible intensity of exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time determined through previous protocol at different sub maximal intensities with the following details:
Visit 1:
The participants will perform exercise at 50% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 2: - The participants will perform exercise at 60% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 3: - The participants will perform exercise 70% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise 80% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise. However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.
Duration Protocol:
This protocol is aimed to determine the best possible duration for exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time and intensity determined through previous protocols for different durations with the following details:
Visit 1:
The participants will perform exercise at optimal timing and intensity determined previously for 15 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 2: - The participants will perform exercise at optimal timing and intensity determined previously for 30 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 3: - The participants will perform exercise at optimal timing and intensity determined previously for 45 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise at optimal timing and intensity determined previously for 60 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.
Analysis Procedure:
Sample analysis:
Blood glucose levels will be determined through glucometer and Insulin levels will be determined through sandwich Elisa. MicroRNAs will be extracted and then analyzed through real-time qPCR or microarray analysis.
- Conditions
- Prediabetes, Exercise, Blood Glucose Profile, Lipid Profile, Optimization, Time
- Being tested
- exercise intervention
- Keywords
- prediabetes, Exercise, Optimization, Time, Intensity, Duration
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
A total of 25 prediabetic adults of either gender will participate in the study they will engage in exercise at intensities of 50%, 60%, 70%, or 80% of their predicted maximum heart rate (PMHR). In duration they will exercise for 15, 30, 45 and 60 minutes, and in timing protocol they will exercise at various time points after having breakfast. Blood samples were collected at four time points i.e. at fasting, pre-exercise and post-exercise at 30 and 60 minutes to measure glucose, insulin, and C-peptide levels.
| Study group | Role | What they receive |
|---|---|---|
| optimizing exercise timing, intensity and duration with Prediabetes post meal | Experimental | The study is a sequential study design where a cohort of 25 will enter timing, intensity and duration protocols of exercise over 12 visits 7 days apart. Receives: Behavioral: exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min, and 120 minutes) on blood glucose levels. The Blood glucose levels will be measured at fasting, pre-exercise, 30 and 60 minutes post-exercise in mg/dL, using a standard glucose meter.
Measured: 8 months
Exercise Timing and Metabolic health: Targeting Blood Insulin in Adults with Prediabetes post meal
his study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min and 120 minutes) on Insulin levels. The Insulin levels will be measured at baseline, pre-exercise, 30 and 60 minutes post exercise, in the prediabetic population, to identify which intensity is the most effective time and improves these metabolic markers. Insulin levels will be measured using enzyme-linked immunosorbent assay (ElISA), reported in μU/mL.
Measured: 8 months
Exercise timings and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on C-peptide levels. C-peptide levels will be assessed at fasting, pre-exercise, and 30 and 60 minutes post exercise using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Measured: 8 months
Exercise timings and Metabolic health: Targeting Lipid profile levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Measured: 8 months
Exercise timings and Metabolic health: Targeting MiRNA 192 expression levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on MiRNA-192. miRNA 192 expression levels will be measured using Real-time quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Measured: 8 months
Exercise Intensities and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on blood glucose levels in a prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Blood glucose levels will be measured at baseline and at each post-exercise interval (30, 60, 90, and 120 minutes) in mg/dL, using a standard glucose meter.
Measured: 8 months
Exercise Intensities and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on insulin levels in the prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Insulin levels will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in μU/mL.
Measured: 8 months
Exercise Intensities and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on C-peptide levels in the prediabetic population, to identify which intensity is the most effective and improves these metabolic markers. It will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in ng/mL.
Measured: 8 months
Exercise Intensities and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Measured: 8 months
Exercise Intensities and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on MiRNA-192. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Measured: 8 months
Exercise duration and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on blood glucose levels. Blood glucose levels will be measured in mg/dL, using a standard glucose meter. The goal is to determine which exercise timing results in the most significant reduction in blood glucose levels.
Measured: 8 months
Exercise duration and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on insulin levels in a prediabetic population, to identify whichduration is the most effective and improves this metabolic marker. insulin levels will be measured at the same intervals using a chemiluminescence immunoassay, reported in μU/mL. This outcome aims to identify the optimal timing for exercise in reducing insulin levels.
Measured: 8 months
Exercise duration and Metabolic health: Targeting C-peptide in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on C-peptide levels in a prediabetic population, to identify which duration is the most effective and improves this metabolic marker. C-peptide levels will be assessed at each time point using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The analysis will focus on the timing of exercise that maximizes reductions in C-peptide levels.
Measured: 8 months
Exercise duration and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on Lipid Profile in a prediabetic population, to identify which duration is the most effective and improves thses metabolic marker. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Measured: 8 months
Exercise duration and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on MiRNA-192 in a prediabetic population, to identify which Duration is the most effective and improves the marker. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start15 Sep 2022
- Primary completion20 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- In this interventional study, we will include prediabetic patients who will undergo three sequential exercise protocols to optimize exercise timing, intensity, and duration. Each protocol is designed to explore a unique combination of these exercise parameters, allowing us to assess the effects on health outcomes relevant to prediabetes management. By using a randomized, cross-over design, participants will experience different exercise regimens, enabling us to compare the impact of each combination on glucose control, cardiovascular health, and overall metabolic function. This study aims to develop evidence-based exercise guidelines specifically tailored to prediabetic individuals.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saman Tauqir, Mphil, Principal investigator, Khyber Medical University Peshawar, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656377
- Sponsor's protocol ID
- DIR/KMU-EB/OE/00060
- Other IDs
- Ref No. 20-16057/NRPU/R&D/HEC
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after getting approval from the principal investigator of the study, data will be kept confidential and the privacy of the data will be ensured using password-protected devices.
Publications
Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A. Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.
PubMed 24243632Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002 Feb;51 Suppl 1:S271-83. doi: 10.2337/diabetes.51.2007.s271.
PubMed 11815492Manders RJ, Van Dijk JW, van Loon LJ. Low-intensity exercise reduces the prevalence of hyperglycemia in type 2 diabetes. Med Sci Sports Exerc. 2010 Feb;42(2):219-25. doi: 10.1249/MSS.0b013e3181b3b16d.
PubMed 19927038Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.
PubMed 18845966
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
- ClinicalTrials.gov ID
- NCT06656377
- Acronym / sponsor ID
- DIR/KMU-EB/OE/00060
- Conditions
- Prediabetes, Exercise, Blood Glucose Profile, Lipid Profile, Optimization, Time
- Keywords
- prediabetes, Exercise, Optimization, Time, Intensity, Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic. The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance adherence in best scientific manner possible.
Detailed description
Participants will be selected from Peshawar and the study will be carried in accordance with the ethical code of research as per the revised (2013) declaration of Helsinki 1975. The volunteers will be recruited through posters, banners and personal contacts. The aims, objectives, purpose and procedure of the study will be explained to each participant. A written informed consent from all the participants will be taken after agreement and they will be informed about their right to leave the trial at any time if they don't want.
After selection, the recruited, participants will be asked to attend the lab for 12 visits over 6 months. On the day of experiment, patients will be received in Lab in fasting state, where baseline measurements, weight, age, BMI, W/H ratio, body composition will be determined. They will be screened for exercise fitness through PAR_Q and exercise readiness questionnaire. Detailed history of the patients (Diabetes Mellitus, medications, and economic conditions) and General Physical Examination will be carried out.
This study will be triphasic during which optimal timing of the exercise in post prandial state, optimal intensity of the exercise and optimal duration of the exercise will be quantified. For this a single cohort of 12 participants will be selected with crossover design who will attend the lab 12 times in total for all phases (04 visits for single phase). Each participant will attend the lab 12 times in total during the intervention. Each participant will be provided with one week time as wash out period.
The details of the actual visits of participants to Physiology Skill lab in detail is as under:
TIMING Protocol:
This protocol is aimed to determine the best possible time for exercise execution in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (7 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at different intervals with the following details:
Visit 1:
The participants will perform exercise 30 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).
Visit 2: - The participants will perform exercise 60 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).
Visit 3: - The participants will perform exercise 90 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise 120 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
This protocol will provide us an optimal time for exercise in post prandial state.
Intensity Protocol:
This protocol is aimed to determine the best possible intensity of exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time determined through previous protocol at different sub maximal intensities with the following details:
Visit 1:
The participants will perform exercise at 50% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 2: - The participants will perform exercise at 60% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 3: - The participants will perform exercise 70% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise 80% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise. However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.
Duration Protocol:
This protocol is aimed to determine the best possible duration for exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time and intensity determined through previous protocols for different durations with the following details:
Visit 1:
The participants will perform exercise at optimal timing and intensity determined previously for 15 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 2: - The participants will perform exercise at optimal timing and intensity determined previously for 30 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit 3: - The participants will perform exercise at optimal timing and intensity determined previously for 45 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
Visit4: - The participants will perform exercise at optimal timing and intensity determined previously for 60 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.
However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.
Analysis Procedure:
Sample analysis:
Blood glucose levels will be determined through glucometer and Insulin levels will be determined through sandwich Elisa. MicroRNAs will be extracted and then analyzed through real-time qPCR or microarray analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this interventional study, we will include prediabetic patients who will undergo three sequential exercise protocols to optimize exercise timing, intensity, and duration. Each protocol is designed to explore a unique combination of these exercise parameters, allowing us to assess the effects on health outcomes relevant to prediabetes management. By using a randomized, cross-over design, participants will experience different exercise regimens, enabling us to compare the impact of each combination on glucose control, cardiovascular health, and overall metabolic function. This study aims to develop evidence-based exercise guidelines specifically tailored to prediabetic individuals.
| Arm | Type | Receives |
|---|---|---|
| optimizing exercise timing, intensity and duration with Prediabetes post meal | Experimental | Behavioral: exercise interventionThe study is a sequential study design where a cohort of 25 will enter timing, intensity and duration protocols of exercise over 12 visits 7 days apart. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prediabetic adults between 20-to-35-year age group with and without a family history of diabetes mellitus will be recruited into the study.
- Diagnosis of prediabetes will be made through HbA1c (prediabetic range is 5·7 - 6·4%), and impaired fasting glucose (fasting plasma glucose 5·6 -6·9 mmol/L) -
Key exclusion criteria (1 listed)
- 1. Participants with type 2 diabetes and other diseases, on lipid-lowering drugs, pregnant and lactating females or participating in some other study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise interventionA total of 25 prediabetic adults of either gender will participate in the study they will engage in exercise at intensities of 50%, 60%, 70%, or 80% of their predicted maximum heart rate (PMHR). In duration they will exercise for 15, 30, 45 and 60 minutes, and in timing protocol they will exercise at various time points after having breakfast. Blood samples were collected at four time points i.e. at fasting, pre-exercise and post-exercise at 30 and 60 minutes to measure glucose, insulin, and C-peptide levels. | Behavioural | optimizing exercise timing, intensity and duration with Prediabetes post meal |
Primary outcome
Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min, and 120 minutes) on blood glucose levels. The Blood glucose levels will be measured at fasting, pre-exercise, 30 and 60 minutes post-exercise in mg/dL, using a standard glucose meter.
Exercise Timing and Metabolic health: Targeting Blood Insulin in Adults with Prediabetes post meal
Time frame: 8 months
his study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min and 120 minutes) on Insulin levels. The Insulin levels will be measured at baseline, pre-exercise, 30 and 60 minutes post exercise, in the prediabetic population, to identify which intensity is the most effective time and improves these metabolic markers. Insulin levels will be measured using enzyme-linked immunosorbent assay (ElISA), reported in μU/mL.
Exercise timings and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on C-peptide levels. C-peptide levels will be assessed at fasting, pre-exercise, and 30 and 60 minutes post exercise using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Exercise timings and Metabolic health: Targeting Lipid profile levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise timings and Metabolic health: Targeting MiRNA 192 expression levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on MiRNA-192. miRNA 192 expression levels will be measured using Real-time quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Exercise Intensities and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on blood glucose levels in a prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Blood glucose levels will be measured at baseline and at each post-exercise interval (30, 60, 90, and 120 minutes) in mg/dL, using a standard glucose meter.
Exercise Intensities and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on insulin levels in the prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Insulin levels will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in μU/mL.
Exercise Intensities and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on C-peptide levels in the prediabetic population, to identify which intensity is the most effective and improves these metabolic markers. It will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in ng/mL.
Exercise Intensities and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise Intensities and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on MiRNA-192. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Exercise duration and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on blood glucose levels. Blood glucose levels will be measured in mg/dL, using a standard glucose meter. The goal is to determine which exercise timing results in the most significant reduction in blood glucose levels.
Exercise duration and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on insulin levels in a prediabetic population, to identify whichduration is the most effective and improves this metabolic marker. insulin levels will be measured at the same intervals using a chemiluminescence immunoassay, reported in μU/mL. This outcome aims to identify the optimal timing for exercise in reducing insulin levels.
Exercise duration and Metabolic health: Targeting C-peptide in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on C-peptide levels in a prediabetic population, to identify which duration is the most effective and improves this metabolic marker. C-peptide levels will be assessed at each time point using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The analysis will focus on the timing of exercise that maximizes reductions in C-peptide levels.
Exercise duration and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on Lipid Profile in a prediabetic population, to identify which duration is the most effective and improves thses metabolic marker. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise duration and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
Time frame: 8 months
This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on MiRNA-192 in a prediabetic population, to identify which Duration is the most effective and improves the marker. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 24243632Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A. Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.
- Background: PubMed 11815492Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002 Feb;51 Suppl 1:S271-83. doi: 10.2337/diabetes.51.2007.s271.
- Background: PubMed 19927038Manders RJ, Van Dijk JW, van Loon LJ. Low-intensity exercise reduces the prevalence of hyperglycemia in type 2 diabetes. Med Sci Sports Exerc. 2010 Feb;42(2):219-25. doi: 10.1249/MSS.0b013e3181b3b16d.
- Background: PubMed 18845966Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.
- Individual participant dataSharing planned: Yes. Data will be shared after getting approval from the principal investigator of the study, data will be kept confidential and the privacy of the data will be ensured using password-protected devices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saman Tauqir, Mphil principal investigator
Khyber Medical University Peshawar, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention in people with Prediabetes and Exercise, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal (time frame: 8 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.