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NCT Number: NCT07061496

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

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.

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Key information

Conditions

Pre Diabetic Behavior Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pre Diabetes

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Preventive Medicine, Combined Military Hospital Nowshera

Nowshera, 25770, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderately intense exercise

Behavioral

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

Other names: Exercise Group

MetFORMIN 500 Mg Oral Tablet

Drug

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

Other names: Metformin Group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight change

    Time frame: Baseline to 12 weeks

    Change in weight in kilograms from baseline to 12 weeks following the two interventions

Sponsors and collaborators

Lead sponsor

Asad Ullah Jan

Other Gov

Collaborators

  • Combined Military Hospital Nowshera

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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