Type 2 Diabetes Mellitus (T2DM)HIITNCT06659848
the Effect of Fasted Versus Post-meal HIIT on Glycemic Control in Men With Type 2 Diabetes Mellitus
A study testing high intensity interval training in people with Type 2 Diabetes Mellitus (T2DM), run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Background: Recently, high intensity interval training (HIIT) has emerged as a promising regimen for the management of type 2 diabetic subjects. However, there is no consensus on the best time for HIIT regarding nutritional status. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- high intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Jun 2024to 20 Oct 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 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Only men diagnosed with T2DM,
- Aged 40-60 years
- Inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months)
Who cannot join
- Subjects treated with exogenous insulin
- Cardiovascular diseases limiting participation in HIIT
- Musculoskeletal diseases limiting participation in HIIT
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11942
About this study
Background: Recently, high intensity interval training (HIIT) has emerged as a promising regimen for the management of type 2 diabetic subjects. However, there is no consensus on the best time for HIIT regarding nutritional status.
Purpose: to investigate the effect of fasted versus postprandial HIIT training on glycemic control in men with type 2 Diabetes Mellitus.
Methods: This study enrolled 123 subjects suffering from type 2 diabetes mellitus with ages between 40 and 60 years. Subjects were divided into 4 groups, The post-breakfast, post-lunch and post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The HIIT program involved 3 sessions weekly for 12 weeks. Glycated hemoglobin, fasting blood glucose, fasting insulin, insulin sensitivity, body composition, and blood lipid values were evaluated pre- and post-intervention.
Read the detailed description
METHODS Study Design This study was performed as a randomized, controlled trial and included four groups. The study procedures were carried out in the department of physical therapy and health rehabilitation, Prince Sattam Bin Abdulaziz University.
Ethical consideration The study protocol was approved by the Standing Committee of Bioethics Research in Prince Sattam bin Abdulaziz University, Saudi Arabia (ID: SCBR-352/2024). The study was conducted in line with the principles of the Declaration of Helsinki. All study participants have signed a written informed consent form. The aim, procedures and potential risks of the study were explained to the study population.
Participants:
A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period.
Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded.
Eligible subjects were randomly assigned to one of four groups. The Fasted-group practiced HIIT prebreakfast in the fasted state (8-12 h fasting). The Post-breakfast, Post-lunch and Post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The primary outcome was glycated hemoglobin (HbA1c). Body composition, fasting blood glucose, fasting insulin, insulin resistance and lipid values were also evaluated. The experimental period was twelve weeks, and all outcomes were measured pre- and post-intervention period.
Sample size calculation The sample size was determined based on an estimated effect size (d = 0.40), derived from changes in HbA1c% observed in Al-Rawaf's study. To reject the null hypothesis, the probability was set at 0.05, with a power of analysis at 90%, calculated using G*power 3.0.10 software (University of Dusseldorf, Dusseldorf, Germany). A total of 96 participants were initially recruited. However, the sample size was increased to 125 to account for an anticipated dropout rate of up to 30%.
Anthropometrics assessments:
All participants were assessed for body weight and height. A weight and height scale (Detecto, made in USA) was used. Body mass index (BMI) was calculated using the following formula:
BMI = weight (kg) / height (m)2 The waist circumferences of all subjects were measured as per instruction. The body fat percentage of each subject was evaluated using InBody 770 multifrequency bioelectrical impedance analysis scale (BIA) (Biospace, Cerritos, California).
Blood sampling and analysis:
Pre- and post-intervention blood samples were obtained from all participants after 12hours overnight fast. Venous blood samples were collected from antecubital vein around 8:00 am. The collected samples were centrifuged at 4°C for 10 min and then stored at -80°C for further analysis. Blood samples were analyzed for glucose, lipid profile including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, plasma triglycerides (Hitachi Automatic Analyzer 7600 Hitachi, Tokyo, Japan). HbA1c levels were measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan). Serum insulin levels were measured by ECLIA using an E-Insulin kit (Roche Diagnostics, Mannheim, Germany). To exclude the potential acute effects of the last exercise bout, postintervention blood samples were collected 48-72 h after the last exercise session. Serum low-density lipoprotein (LDL) cholesterol levels were calculated using the Friedewald formula.
Exercise test In order to determine exercise training intensity all subjects underwent performed an incremental maximal cardiopulmonary exercise test according to standard Bruce protocol to determine the peak heart rate. A stationary CPET system (Quark CPET, COSMED, Italy) on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) was used to perform the test. The flow sensor was calibrated using a 3.0-L syringe. CO2 and O2 sensors were calibrated against known gases before each test. The test was terminated when subjects reached the point of volitional exhaustion. Reaching peak effort was confirmed when respiratory gas exchange ratio was ≥1.10, in combination with dyspnea, and leg and/or general fatigue.
Exercise protocol The subjects in the four groups performed 12 weeks of supervised HIIE program on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) with a rate of three sessions weekly. The session commenced with a 5 min warming-up and concluded with a 5 min cooling down period. The exercise effort component consisted of 5 intervals of HIIT. Each interval continues for four min of HIIT with exercise intensity ranging from 75% to 90% of the peak heart rate. Each active recovery period between exercise intervals included moderate exercise at intensity of 50% to 60% of the peak heart rate. Every 3 weeks, the exercise intensity was increased by 5% starting with 75% of the HRmax in the first 3 weeks, 80% in the following 3 weeks and progressed to 90% the HRmax in the last 3 weeks. The subject's heart rate throughout the HIIT session was monitored using a polar heart rate monitor (Polar, Kempele, Finland).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- high intensity interval training
- Keywords
- Diabetes Mellitus, High Intensity Exercise, Glycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity interval trainingOther
The subjects in the four groups performed 12 weeks of supervised HIIE program on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) with a rate of three sessions weekly. The session commenced with a 5 min warming-up and concluded with a 5 min cooling down period. The exercise effort component consisted of 5 intervals of HIIT. Each interval continues for four min of HIIT with exercise intensity ranging from 75% to 90% of the peak heart rate. Each active recovery period between exercise intervals included moderate exercise at intensity of 50% to 60% of the peak heart rate. Every 3 weeks, the exercise intensity was increased by 5% starting with 75% of the HRmax in the first 3 weeks, 80% in the following 3 weeks and progressed to 90% the HRmax in the last 3 weeks. The subject's heart rate throughout the HIIT session was monitored using a polar heart rate monitor (Polar, Kempele, Finland).
| Study group | Role | What they receive |
|---|---|---|
| Fasted-group | Experimental | practiced HIIT prebreakfast in the fasted state (8-12 h fasting) Receives: Other: high intensity interval training |
| Post-breakfast | Experimental | practiced HIIT 2 hours after breakfast Receives: Other: high intensity interval training |
| Post-lunch | Experimental | practiced HIIT 2 hours after lunch Receives: Other: high intensity interval training |
| Post-dinner | Experimental | practiced HIIT 2 hours after dinner Receives: Other: high intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glycated hemoglobin
Percentage of glycated hemoglobin (HbA1c) levels are measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan).
Measured: 3 months
Secondary outcomes (7)
Body weight in kg
All participants were assessed for body weight and height. A weight and height scale (Detecto, made in USA) was used.
Measured: 3 months
Body Mass Index (BMI) in kg/m2
Body mass index (BMI) was calculated using the following formula:
BMI = weight (kg) / height (m)2
Measured: 3 months
Waist Circumference in cm
The waist circumferences of all subjects were measured as per instruction.
Measured: 3 months
Concentration of Fasting plasma insulin in μU/ml
Pre- and post-intervention blood samples were obtained from all participants after 12hours overnight fast. Venous blood samples were collected from antecubital vein around 8:00 am. The collected samples were centrifuged at 4°C for 10 min and then stored at -80°C for further analysis.
Measured: 3 months
Concentration of Fasting blood glucose in mg/dl
Pre- and post-intervention blood samples were obtained from all participants after 12hours overnight fast. Venous blood samples were collected from antecubital vein around 8:00 am. The collected samples were centrifuged at 4°C for 10 min and then stored at -80°C for further analysis.
Measured: 3 months
concentration of total blood cholesterol in mg/dl
Blood samples were analyzed for glucose, lipid profile including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, plasma triglycerides (Hitachi Automatic Analyzer 7600 Hitachi, Tokyo, Japan).
Measured: 3 months
concentration of total blood triglyceride in mg/dl
Blood samples were analyzed for glucose, lipid profile including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, plasma triglycerides (Hitachi Automatic Analyzer 7600 Hitachi, Tokyo, Japan).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start20 Jun 2024
- Primary completion30 Aug 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period. Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded. Eligible subjects were randomly assigned to one of four groups. The Fasted-group practiced HIIT prebreakfast in the fasted state (8-12 h fasting). The Post-breakfast, Post-lunch and Post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The primary outcome was gly
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Saied Mohammad, Prince Sattam Bin Abdulaziz University
- Investigators
- Ahmed S Ahmed, PhD, Principal investigator, 1Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659848
- Sponsor's protocol ID
- SCBR-352/2024
- Other IDs
- 2023/03/26426
- Acronym
- HIIT
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no need
Publications
Mancilla R, Brouwers B, Schrauwen-Hinderling VB, Hesselink MKC, Hoeks J, Schrauwen P. Exercise training elicits superior metabolic effects when performed in the afternoon compared to morning in metabolically compromised humans. Physiol Rep. 2021 Jan;8(24):e14669. doi: 10.14814/phy2.14669.
PubMed 33356015Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
PubMed 23002086Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
PubMed 26258597Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
PubMed 30426166Verboven K, Wens I, Vandenabeele F, Stevens AN, Celie B, Lapauw B, Dendale P, VAN Loon LJC, Calders P, Hansen D. Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes. Med Sci Sports Exerc. 2020 Mar;52(3):720-728. doi: 10.1249/MSS.0000000000002165.
PubMed 31652237Nygaard H, Ronnestad BR, Hammarstrom D, Holmboe-Ottesen G, Hostmark AT. Effects of Exercise in the Fasted and Postprandial State on Interstitial Glucose in Hyperglycemic Individuals. J Sports Sci Med. 2017 Jun 1;16(2):254-263. eCollection 2017 Jun.
PubMed 28630579Peddie MC, Bone JL, Rehrer NJ, Skeaff CM, Gray AR, Perry TL. Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. Am J Clin Nutr. 2013 Aug;98(2):358-66. doi: 10.3945/ajcn.112.051763. Epub 2013 Jun 26.
PubMed 23803893Gillen JB, Little JP, Punthakee Z, Tarnopolsky MA, Riddell MC, Gibala MJ. Acute high-intensity interval exercise reduces the postprandial glucose response and prevalence of hyperglycaemia in patients with type 2 diabetes. Diabetes Obes Metab. 2012 Jun;14(6):575-7. doi: 10.1111/j.1463-1326.2012.01564.x. Epub 2012 Feb 20.
PubMed 22268455Hamasaki H. Daily physical activity and type 2 diabetes: A review. World J Diabetes. 2016 Jun 25;7(12):243-51. doi: 10.4239/wjd.v7.i12.243.
PubMed 27350847Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.
PubMed 35029593American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.
PubMed 33298413Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Fasted Versus Post-meal HIIT on Glycemic Control in Men With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06659848
- Acronym / sponsor ID
- HIIT / SCBR-352/2024
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Diabetes Mellitus, High Intensity Exercise, Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 26 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.
Background: Recently, high intensity interval training (HIIT) has emerged as a promising regimen for the management of type 2 diabetic subjects. However, there is no consensus on the best time for HIIT regarding nutritional status.
Purpose: to investigate the effect of fasted versus postprandial HIIT training on glycemic control in men with type 2 Diabetes Mellitus.
Methods: This study enrolled 123 subjects suffering from type 2 diabetes mellitus with ages between 40 and 60 years. Subjects were divided into 4 groups, The post-breakfast, post-lunch and post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The HIIT program involved 3 sessions weekly for 12 weeks. Glycated hemoglobin, fasting blood glucose, fasting insulin, insulin sensitivity, body composition, and blood lipid values were evaluated pre- and post-intervention.
Detailed description
METHODS Study Design This study was performed as a randomized, controlled trial and included four groups. The study procedures were carried out in the department of physical therapy and health rehabilitation, Prince Sattam Bin Abdulaziz University.
Ethical consideration The study protocol was approved by the Standing Committee of Bioethics Research in Prince Sattam bin Abdulaziz University, Saudi Arabia (ID: SCBR-352/2024). The study was conducted in line with the principles of the Declaration of Helsinki. All study participants have signed a written informed consent form. The aim, procedures and potential risks of the study were explained to the study population.
Participants:
A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period.
Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded.
Eligible subjects were randomly assigned to one of four groups. The Fasted-group practiced HIIT prebreakfast in the fasted state (8-12 h fasting). The Post-breakfast, Post-lunch and Post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The primary outcome was glycated hemoglobin (HbA1c). Body composition, fasting blood glucose, fasting insulin, insulin resistance and lipid values were also evaluated. The experimental period was twelve weeks, and all outcomes were measured pre- and post-intervention period.
Sample size calculation The sample size was determined based on an estimated effect size (d = 0.40), derived from changes in HbA1c% observed in Al-Rawaf's study. To reject the null hypothesis, the probability was set at 0.05, with a power of analysis at 90%, calculated using G*power 3.0.10 software (University of Dusseldorf, Dusseldorf, Germany). A total of 96 participants were initially recruited. However, the sample size was increased to 125 to account for an anticipated dropout rate of up to 30%.
Anthropometrics assessments:
All participants were assessed for body weight and height. A weight and height scale (Detecto, made in USA) was used. Body mass index (BMI) was calculated using the following formula:
BMI = weight (kg) / height (m)2 The waist circumferences of all subjects were measured as per instruction. The body fat percentage of each subject was evaluated using InBody 770 multifrequency bioelectrical impedance analysis scale (BIA) (Biospace, Cerritos, California).
Blood sampling and analysis:
Pre- and post-intervention blood samples were obtained from all participants after 12hours overnight fast. Venous blood samples were collected from antecubital vein around 8:00 am. The collected samples were centrifuged at 4°C for 10 min and then stored at -80°C for further analysis. Blood samples were analyzed for glucose, lipid profile including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, plasma triglycerides (Hitachi Automatic Analyzer 7600 Hitachi, Tokyo, Japan). HbA1c levels were measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan). Serum insulin levels were measured by ECLIA using an E-Insulin kit (Roche Diagnostics, Mannheim, Germany). To exclude the potential acute effects of the last exercise bout, postintervention blood samples were collected 48-72 h after the last exercise session. Serum low-density lipoprotein (LDL) cholesterol levels were calculated using the Friedewald formula.
Exercise test In order to determine exercise training intensity all subjects underwent performed an incremental maximal cardiopulmonary exercise test according to standard Bruce protocol to determine the peak heart rate. A stationary CPET system (Quark CPET, COSMED, Italy) on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) was used to perform the test. The flow sensor was calibrated using a 3.0-L syringe. CO2 and O2 sensors were calibrated against known gases before each test. The test was terminated when subjects reached the point of volitional exhaustion. Reaching peak effort was confirmed when respiratory gas exchange ratio was ≥1.10, in combination with dyspnea, and leg and/or general fatigue.
Exercise protocol The subjects in the four groups performed 12 weeks of supervised HIIE program on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) with a rate of three sessions weekly. The session commenced with a 5 min warming-up and concluded with a 5 min cooling down period. The exercise effort component consisted of 5 intervals of HIIT. Each interval continues for four min of HIIT with exercise intensity ranging from 75% to 90% of the peak heart rate. Each active recovery period between exercise intervals included moderate exercise at intensity of 50% to 60% of the peak heart rate. Every 3 weeks, the exercise intensity was increased by 5% starting with 75% of the HRmax in the first 3 weeks, 80% in the following 3 weeks and progressed to 90% the HRmax in the last 3 weeks. The subject's heart rate throughout the HIIT session was monitored using a polar heart rate monitor (Polar, Kempele, Finland).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period. Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded. Eligible subjects were randomly assigned to one of four groups. The Fasted-group practiced HIIT prebreakfast in the fasted state (8-12 h fasting). The Post-breakfast, Post-lunch and Post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The primary outcome was gly
| Arm | Type | Receives |
|---|---|---|
| Fasted-group | Experimental | Other: high intensity interval trainingpracticed HIIT prebreakfast in the fasted state (8-12 h fasting) |
| Post-breakfast | Experimental | Other: high intensity interval trainingpracticed HIIT 2 hours after breakfast |
| Post-lunch | Experimental | Other: high intensity interval trainingpracticed HIIT 2 hours after lunch |
| Post-dinner | Experimental | Other: high intensity interval trainingpracticed HIIT 2 hours after dinner |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Only men diagnosed with T2DM,
- Aged 40-60 years
- Inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months)
Key exclusion criteria (3 listed)
- Subjects treated with exogenous insulin
- Cardiovascular diseases limiting participation in HIIT
- Musculoskeletal diseases limiting participation in HIIT
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 |
|---|---|---|
| high intensity interval trainingThe subjects in the four groups performed 12 weeks of supervised HIIE program on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) with a rate of three sessions weekly. The session commenced with a 5 min warming-up and concluded with a 5 min cooling down period. The exercise effort component consisted of 5 intervals of HIIT. Each interval continues for four min of HIIT with exercise intensity ranging from 75% to 90% of the peak heart rate. Each active recovery period between exercise intervals included moderate exercise at intensity of 50% to 60% of the peak heart rate. Every 3 weeks, the exercise intensity was increased by 5% starting with 75% of the HRmax in the first 3 weeks, 80% in the following 3 weeks and progressed to 90% the HRmax in the last 3 weeks. The subject's heart rate throughout the HIIT session was monitored using a polar heart rate monitor (Polar, Kempele, Finland). | Other | Fasted-group, Post-breakfast, Post-dinner, Post-lunch |
Primary outcome
Percentage of glycated hemoglobin
Time frame: 3 months
Percentage of glycated hemoglobin (HbA1c) levels are measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan).
7 secondary outcomes
Body weight in kg
Time frame: 3 months
Body Mass Index (BMI) in kg/m2
Time frame: 3 months
Waist Circumference in cm
Time frame: 3 months
Concentration of Fasting plasma insulin in μU/ml
Time frame: 3 months
Concentration of Fasting blood glucose in mg/dl
Time frame: 3 months
concentration of total blood cholesterol in mg/dl
Time frame: 3 months
concentration of total blood triglyceride in mg/dl
Time frame: 3 months
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 26 Oct 2024.
- Background: PubMed 33356015Mancilla R, Brouwers B, Schrauwen-Hinderling VB, Hesselink MKC, Hoeks J, Schrauwen P. Exercise training elicits superior metabolic effects when performed in the afternoon compared to morning in metabolically compromised humans. Physiol Rep. 2021 Jan;8(24):e14669. doi: 10.14814/phy2.14669.
- Background: PubMed 23002086Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
- Background: PubMed 26258597Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
- Background: PubMed 30426166Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
- Background: PubMed 31652237Verboven K, Wens I, Vandenabeele F, Stevens AN, Celie B, Lapauw B, Dendale P, VAN Loon LJC, Calders P, Hansen D. Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes. Med Sci Sports Exerc. 2020 Mar;52(3):720-728. doi: 10.1249/MSS.0000000000002165.
- Background: PubMed 28630579Nygaard H, Ronnestad BR, Hammarstrom D, Holmboe-Ottesen G, Hostmark AT. Effects of Exercise in the Fasted and Postprandial State on Interstitial Glucose in Hyperglycemic Individuals. J Sports Sci Med. 2017 Jun 1;16(2):254-263. eCollection 2017 Jun.
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- Individual participant dataSharing planned: No. no need
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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.
Ahmed S Ahmed, PhD principal investigator
1Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity interval training in people with Type 2 Diabetes Mellitus (T2DM), run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 3 inclusion and 3 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 26 Oct 2024. 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 Saudi Arabia. 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?
Percentage of glycated hemoglobin (time frame: 3 months). 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 NCT06659848, which also lists 12 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 26 Oct 2024.