Comparative Effects of Exercise and Metformin on Glycemic Control in Prediabetic Adults

Not Applicable

Not yet recruiting

• Conditions: Pre Diabetic; Pre Diabetes
• Interventions: Behavioral: Moderately intense exercise; Drug: MetFORMIN 500 Mg Oral Tablet

• Registration Number: NCT07061496
• Lead Sponsor: Umair Ali

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-10
• Primary Completion: 2026-02-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Moderately intense exercise	Moderate aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.
Metformin Group	MetFORMIN 500 Mg Oral Tablet	Participants will receive oral metformin 500 mg twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Weight change	Baseline to 12 weeks	Change in weight in kilograms from baseline to 12 weeks following the two interventions

Trial Locations

Locations (1)

Department of Preventive Medicine, Combined Military Hospital Nowshera; 🇵🇰 Nowshera, Pakistan

Department of Preventive Medicine, Combined Military Hospital Nowshera

🇵🇰Nowshera, Pakistan

Umair Ali

Contact

00923215171052

alisq2002@hotmail.com