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

NCT ID: NCT07061496

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-03-15

Brief Summary

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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

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Conditions

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Pre Diabetic Pre Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Group

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

Group Type EXPERIMENTAL

Moderately intense exercise

Intervention Type BEHAVIORAL

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

Metformin Group

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

Group Type ACTIVE_COMPARATOR

MetFORMIN 500 Mg Oral Tablet

Intervention Type DRUG

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

Interventions

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Moderately intense exercise

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

Intervention Type BEHAVIORAL

MetFORMIN 500 Mg Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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Exercise Group Metformin Group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMH Nowshera

UNKNOWN

Sponsor Role collaborator

Umair Ali

OTHER_GOV

Sponsor Role lead

Responsible Party

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Umair Ali

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Umair Ali

Role: PRINCIPAL_INVESTIGATOR

CMH Nowshera

Locations

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Department of Preventive Medicine, Combined Military Hospital Nowshera

Nowshera, , Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Umair Ali, MBBS,M.Sc

Role: CONTACT

+923215171052

Asad Jan, MBBS, FCPS

Role: CONTACT

00923445515919

Facility Contacts

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Umair Ali

Role: primary

00923215171052

Other Identifiers

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CMHNSR-REF-17

Identifier Type: -

Identifier Source: org_study_id

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