Exercise Intervention Combined With Metformin in the Treatment of Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Other: Exercise training
- Registration Number
- NCT05004948
- Lead Sponsor
- Prince Sattam Bin Abdulaziz University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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.
- Cancer
- Pregnancy
- Corticosteroid medications
- Uncontrolled systemic diseases
- Any physical limits that affect exercise training
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic exercise program Exercise training This group has conducted an aerobic exercise program ( 50-70% maxHR, for 40-50 min) thrice weekly for consecutive twelve weeks plus metformin medication. Resistance exercise group Exercise training 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.
- Primary Outcome Measures
Name Time Method Change in Glycated hemoglobin% (HbA1c%) 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.
- Secondary Outcome Measures
Name Time Method Fasting blood glucose (FBG) Pre and post 12-week intervention It was were evaluated before and after study intervention by collecting blood samples after fasting 10 hours overnight.
homeostatic model assessment of insulin resistance (HOMA-IR) 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.
The maximum oxygen uptake (VO2max) 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.
Trial Locations
- Locations (1)
Prince Sattam bin Abdulaziz University
🇸🇦Al Kharj, Riyadh, Saudi Arabia