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NCT Number: NCT05004948

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2021
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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