Type 2 Diabetes MellitusNCT04924777
Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus
A study testing Brisk Walk, Strength training and Aerobic Exercises in people with Type 2 Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Brisk Walk, Strength training and Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 31 Jul 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Male/female
- Diabetic type 2 patients
- Age: 30-70 years
- BMI >25
- Overweight
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- Fat % in male> 25
- Fat % in female >35
- HbA1c level more than 48mmol/mol or >6.5%
- Fasting Plasma Glucose level >126 mg/dl (7.0 mmol/l)
- Random Plasma glucose level >200 mg/dl (11.1 mmol/l)
- Physically active ( have no mobility problems)
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Type 1 diabetes
- Insulin dependant type 2 diabetes
- Gestational Diabetes
- Hypertension
- Cigarette smoking
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- Cardiovascular Disease
- Cerebrovascular disease
- Cardiopulmonary Disorders
- Cognition Problems
- Peripheral Artery Disease
- Dyslipidemia
- Proliferative or preproliferative retinopathy
- Nephropathy
- Neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
The study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.
Read the detailed description
To the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in Pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Brisk Walk, Strength training, Aerobic Exercises
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk WalkOther
1-Brisk walk for 30 minutes 2-5 days a week 3-3months
Strength trainingOther
1-Strength Training Exercises for 30 minutes. 2-5 days a week 3-3 months
Aerobic ExercisesOther
1-Aerobic exercises for 30 minutes 2-5 Days a week 3-3months
| Study group | Role | What they receive |
|---|---|---|
| Brisk walk | Experimental | Not described Receives: Other: Brisk Walk; Other: Strength training; Other: Aerobic Exercises |
| Aerobic Training | Experimental | Not described Receives: Other: Brisk Walk; Other: Strength training; Other: Aerobic Exercises |
| Strength Training | Experimental | Not described Receives: Other: Brisk Walk; Other: Strength training; Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Levels
Reduction in HbA1c levels
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 posted14 Jun 2021
- Study start1 Apr 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmad Awan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924777
- Sponsor's protocol ID
- REC/0929 Zainab Qadri
- Status last verified
- Nov 2021
- First submitted
- 11 Jun 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04924777
- Acronym / sponsor ID
- REC/0929 Zainab Qadri
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 14 Jun 2021 (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 study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.
Detailed description
To the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in Pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brisk walk | Experimental | Other: Brisk Walk, Other: Strength training, Other: Aerobic Exercises |
| Aerobic Training | Experimental | Other: Brisk Walk, Other: Strength training, Other: Aerobic Exercises |
| Strength Training | Experimental | Other: Brisk Walk, Other: Strength training, Other: Aerobic Exercises |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants falling in this category would be recruited into the study.
- Male/female
- Diabetic type 2 patients
- Age: 30-70 years
- BMI >25
Key exclusion criteria (15 listed)
- Participant failing to fall in this category would be excluded of the study.
- Type 1 diabetes
- Insulin dependant type 2 diabetes
- Gestational Diabetes
- Hypertension
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 |
|---|---|---|
| Brisk Walk1-Brisk walk for 30 minutes 2-5 days a week 3-3months | Other | Aerobic Training, Brisk walk, Strength Training |
| Strength training1-Strength Training Exercises for 30 minutes. 2-5 days a week 3-3 months | Other | Aerobic Training, Brisk walk, Strength Training |
| Aerobic Exercises1-Aerobic exercises for 30 minutes 2-5 Days a week 3-3months | Other | Aerobic Training, Brisk walk, Strength Training |
Primary outcome
HbA1c Levels
Time frame: 3 months
Reduction in HbA1c levels
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 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Waqar Ahmad Awan principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brisk Walk, Strength training and Aerobic Exercises in people with Type 2 Diabetes Mellitus, run by Riphah International University 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 12 inclusion and 15 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 Nov 2021. 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?
HbA1c Levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2021.