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

NCT07061496 | Completed

• 1 other identifier: CMHNSR-REF-17
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetic; Pre Diabetes

Keywords

Pre diabetic; Exercise; Metformin

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks

  HbA1c (%) will be measured to assess glycemic improvement following 12 weeks of intervention.

  Baseline and 12 week

Secondary Outcomes (1)

• Weight change

  Baseline to 12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Moderate aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.

Behavioral: Moderately intense exercise

Metformin Group

ACTIVE COMPARATOR

Participants will receive oral metformin 500 mg twice daily for 12 weeks.

Drug: MetFORMIN 500 Mg Oral Tablet

Interventions

MetFORMIN 500 Mg Oral Tablet DRUG

Participants will receive oral metformin 500 mg twice daily for 12 weeks.

Also known as: Metformin Group

Metformin Group

Moderately intense exercise BEHAVIORAL

Structured moderate-intensity aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.

Also known as: Exercise Group

Exercise Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asad Ullah Jan: lead
• Combined Military Hospital Nowshera: collaborator

Study Sites (1)

Department of Preventive Medicine, Combined Military Hospital Nowshera

Nowshera, 25770, Pakistan

Location

MeSH Terms

Conditions

Glucose Intolerance; Motor Activity

Interventions

Metformin; Tablets

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Umair Ali

  CMH Nowshera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Psychiatrist

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 10, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)