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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistance exercise group<br>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<br>* 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.<br>* Other names: Resistance and aerobic exercise program;|
| Active Comparator: Aerobic exercise program<br>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<br>* 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.<br>* Other names: Resistance and aerobic exercise program;|
| No Intervention: Metformin group<br>This group received only metformin without any exercise intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycated hemoglobin% (HbA1c%) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance exercise, Aerobic exercise, Metformin, Insulin resistance