Pre Diabetic, Pre Diabetes
Conditions
Keywords
Pre diabetic, Exercise, Metformin
Brief 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. 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.
Interventions
BEHAVIORALModerately intense exercise
Structured moderate-intensity aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.
Participants will receive oral metformin 500 mg twice daily for 12 weeks.
Sponsors
CMH Nowshera
Umair Ali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) * Known allergy or contraindication to metformin * Alcohol or substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks | Baseline and 12 week | HbA1c (%) will be measured to assess glycemic improvement following 12 weeks of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Baseline to 12 weeks | Change in weight in kilograms from baseline to 12 weeks following the two interventions |
Countries
Pakistan
Contacts
Primary ContactUmair Ali, MBBS,M.Sc
Backup ContactAsad Jan, MBBS, FCPS
Outcome results
None listed