NCT07061496

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 2, 2025

Last Update Submit

July 22, 2025

Conditions

Pre DiabeticPre Diabetes

Keywords

Pre diabeticExerciseMetformin

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

Moderately intense exerciseBEHAVIORAL

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
MetFORMIN 500 Mg Oral TabletDRUG

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

Also known as: Metformin Group
Metformin Group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Preventive Medicine, Combined Military Hospital Nowshera

Nowshera, 25770, Pakistan

Location

MeSH Terms

Conditions

Glucose IntoleranceMotor Activity

Interventions

MetforminTablets

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical Preparations

Study Officials

  • Umair Ali

    CMH Nowshera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umair Ali, MBBS,M.Sc

CONTACT

+923215171052alisq2002@hotmail.com

Asad Jan, MBBS, FCPS

CONTACT

00923445515919asad2097@gmail.com

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
Dr

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

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

To maintain patients confidentiality

Locations

PA(1)