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

Umair Ali

Status: Begins enrollment this month

Conditions: Pre Diabetes; Pre Diabetic

Treatments: Behavioral: Moderately intense exercise; Drug: MetFORMIN 500 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07061496

CMHNSR-REF-17

Details and patient eligibility

About

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.

Enrollment: 226 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Exercise Group

Experimental group

Description:

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

Treatment:

Behavioral: Moderately intense exercise

Metformin Group

Active Comparator group

Description:

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

Treatment:

Drug: MetFORMIN 500 Mg Oral Tablet