Exercise Intervention Combined With Metformin in the Treatment of Type 2 Diabetes

August 12, 2021 updated by: Prince Sattam Bin Abdulaziz University

Resistance Exercise Versus Aerobic Exercise Combined With Metformin Therapy in the Treatment of Type 2 Diabetes: A 12-Week Comparative Clinical Study

Background: Both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients. This study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (T2DM), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients. This study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients.

Methods: A total of fifty-seven T2DM patients with a mean age of 46.2±8.3 years were randomized to three study groups; each group included nineteen patients. The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), and maximal oxygen uptake (VO2max) were evaluated before and after study intervention.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh
      • Al Kharj, Riyadh, Saudi Arabia, 11942
        • Prince Sattam Bin Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of T2DM
  • Glycated hemoglobin (HbA1c) ≥8.0%
  • A previous inactive lifestyle
  • Not receiving insulin or diabetic medications except for metformin
  • Metformin dosage of 1000-1500 mg daily.

Exclusion Criteria:

  • Cancer
  • Pregnancy
  • Corticosteroid medications
  • Uncontrolled systemic diseases
  • Any physical limits that affect exercise training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resistance exercise group
This group has conducted a resistance exercise program (50-60% of 1RM, for 40-50 min) thrice weekly for consecutive twelve weeks plus metformin medication.
Other: Exercise training
The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks.
Other Names:
  • Resistance and aerobic exercise program
Active Comparator: Aerobic exercise program
This group has conducted an aerobic exercise program ( 50-70% maxHR, for 40-50 min) thrice weekly for consecutive twelve weeks plus metformin medication.
Other: Exercise training
The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks.
Other Names:
  • Resistance and aerobic exercise program
No Intervention: Metformin group
This group received only metformin without any exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated hemoglobin% (HbA1c%)
Time Frame: Pre and post 12-week intervention
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.
Pre and post 12-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose (FBG)
Time Frame: Pre and post 12-week intervention
It was were evaluated before and after study intervention by collecting blood samples after fasting 10 hours overnight.
Pre and post 12-week intervention
homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame: Pre and post 12-week intervention
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.
Pre and post 12-week intervention
The maximum oxygen uptake (VO2max)
Time Frame: Pre and post 12-week intervention

It was assessed pre- and post-intervention on an electrical cycle ergometer (PravoMedics, Salt Lake City, UT, USA) based on an incremental cycling exercise test. The protocol was initiated with 2 min warming-up at a workload of 30W followed every 2 min by a 30W increase until the patient reaches volitional exhaustion.

During exercise protocol, the oxygen consumption was measured using a breath-by-breath gas analyzer device (FitMate Cosmed, Rome, Italy). VO2max was estimated as the highest average value of 30-s. The technician encouraged the individuals during the last part of the test to generate the maximal effort until voluntary termination. 5-10 min after ending the incremental phase, VO2max value was verified through conducting a supramaximal constant effort to exhaustion based on the criteria for determining VO2max.
Pre and post 12-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince Sattam Bin Abdulaziz University

Investigators

  • Principal Investigator: Walid Kamal Abdelbasset, PhD, Prince Sattam Bin Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

August 7, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHPT/018/029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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