Pre DiabeticNCT07061496
Comparative Effects of Exercise and Metformin on Glycemic Control in Prediabetic Adults
A study testing Moderately intense exercise and MetFORMIN 500 Mg Oral Tablet in people with Pre Diabetic and Pre Diabetes, run by Asad Ullah Jan at 1 site in Pakistan.
Trial summary
This study is being done to compare the effect of regular exercise and metformin in people who have prediabetes. It is a community-based, open-label, randomized trial in which eligible participants will be divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Pre Diabetic, Pre Diabetes
- What is being tested?
- Moderately intense exercise and MetFORMIN 500 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2025to 15 Mar 2026
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 59 years
- Diagnosed with prediabetes based on ADA criteria (FPG: 100-125 mg/dL or HbA1c: 5.7-6.4%)
- Stable HbA1c levels (no significant fluctuation in the last 3 months)
- Body Mass Index (BMI) less than 30 kg/m²
- Willing and able to provide written informed consent
- Willing to participate in the assigned intervention (exercise or metformin) for 12 weeks
- Residing within the community and able to attend scheduled follow-ups
Who cannot join
- Age 60 years or older
- Diagnosis of Type 2 Diabetes Mellitus (T2DM) or use of anti-diabetic medications
- Family history of diabetes in first-degree relatives (parent or sibling)
- Known cardiovascular, renal, or hepatic disease
- Pregnancy or lactation
- Physical disability or limitation that would interfere with performing moderate-intensity exercise
Show all 9Show fewer
- Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
- Known allergy or contraindication to metformin
- Alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Preventive Medicine, Combined Military Hospital Nowshera
Nowshera, 25770
About this study
Official title: Comparative Effects of Exercise and Metformin on Glycemic Control in Prediabetic Adults: A Community-Based, Open-Label, Randomized Trial in a Low-Resource Setting
This study is being done to compare the effect of regular exercise and metformin in people who have prediabetes. It is a community-based, open-label, randomized trial in which eligible participants will be divided into two groups. One group will do moderate physical exercise, and the other group will take metformin for 12 weeks. We will check their fasting blood sugar and HbA1c before and after the treatment to see which method works better for controlling sugar levels. The study is being done in a low-resource community setup to see which option is more practical and effective in real-life Pakistani settings.
- Conditions
- Pre Diabetic, Pre Diabetes
- Being tested
- Moderately intense exercise, MetFORMIN 500 Mg Oral Tablet
- Keywords
- Pre diabetic, Exercise, Metformin
- Medical subject headings
- Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately intense exerciseBehavioural
Also called Exercise Group
Structured moderate-intensity aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.
MetFORMIN 500 Mg Oral TabletDrug
Also called Metformin Group
Participants will receive oral metformin 500 mg twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Moderate aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks. Receives: Behavioral: Moderately intense exercise |
| Metformin Group | Active comparator | Participants will receive oral metformin 500 mg twice daily for 12 weeks. Receives: Drug: MetFORMIN 500 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks
HbA1c (%) will be measured to assess glycemic improvement following 12 weeks of intervention.
Measured: Baseline and 12 week
Secondary outcomes (1)
Weight change
Change in weight in kilograms from baseline to 12 weeks following the two interventions
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Aug 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabeticStudies 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
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asad Ullah Jan
- Sponsor type
- Other government
- Collaborators
- Combined Military Hospital Nowshera
- Responsible party
- Sponsor-investigator, Asad Ullah Jan, Combined Military Hospital Nowshera
- Investigators
- Umair Ali, Principal investigator, CMH Nowshera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061496
- Sponsor's protocol ID
- CMHNSR-REF-17
- Status last verified
- May 2026
- First submitted
- 2 Jul 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To maintain patients confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Exercise and Metformin on Glycemic Control in Prediabetic Adults: A Community-Based, Open-Label, Randomized Trial in a Low-Resource Setting
- ClinicalTrials.gov ID
- NCT07061496
- Acronym / sponsor ID
- CMHNSR-REF-17
- Conditions
- Pre Diabetic, Pre Diabetes
- Keywords
- Pre diabetic, Exercise, Metformin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Asad Ullah JanOther government
- Collaborators
- Combined Military Hospital Nowshera
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 11 Jul 2025 (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.
This study is being done to compare the effect of regular exercise and metformin in people who have prediabetes. It is a community-based, open-label, randomized trial in which eligible participants will be divided into two groups. One group will do moderate physical exercise, and the other group will take metformin for 12 weeks. We will check their fasting blood sugar and HbA1c before and after the treatment to see which method works better for controlling sugar levels. The study is being done in a low-resource community setup to see which option is more practical and effective in real-life Pakistani settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Moderately intense exerciseModerate aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks. |
| Metformin Group | Active comparator | Drug: MetFORMIN 500 Mg Oral TabletParticipants will receive oral metformin 500 mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 59 years
- Diagnosed with prediabetes based on ADA criteria (FPG: 100-125 mg/dL or HbA1c: 5.7-6.4%)
- Stable HbA1c levels (no significant fluctuation in the last 3 months)
- Body Mass Index (BMI) less than 30 kg/m²
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Age 60 years or older
- Diagnosis of Type 2 Diabetes Mellitus (T2DM) or use of anti-diabetic medications
- Family history of diabetes in first-degree relatives (parent or sibling)
- Known cardiovascular, renal, or hepatic disease
- Pregnancy or lactation
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 |
|---|---|---|
| Moderately intense exerciseAlso: Exercise GroupStructured moderate-intensity aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks. | Behavioural | Exercise Group |
| MetFORMIN 500 Mg Oral TabletAlso: Metformin GroupParticipants will receive oral metformin 500 mg twice daily for 12 weeks. | Drug | Metformin Group |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks
Time frame: Baseline and 12 week
HbA1c (%) will be measured to assess glycemic improvement following 12 weeks of intervention.
1 secondary outcome
Weight change
Time frame: Baseline to 12 weeks
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 7 May 2026.
- Individual participant dataSharing planned: No. To maintain patients confidentiality
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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.
Umair Ali principal investigator
CMH Nowshera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately intense exercise and MetFORMIN 500 Mg Oral Tablet in people with Pre Diabetic and Pre Diabetes, run by Asad Ullah Jan 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 7 inclusion and 9 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 7 May 2026. 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?
Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks (time frame: Baseline and 12 week). 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 7 May 2026.