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

P

Prince Sattam Bin Abdulaziz University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT05004948
RHPT/018/029

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

35 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 3 patient groups

Resistance exercise group
Active Comparator group
Description:
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.
Treatment:
Other: Exercise training
Aerobic exercise program
Active Comparator group
Description:
This group has conducted an aerobic exercise program ( 50-70% maxHR, for 40-50 min) thrice weekly for consecutive twelve weeks plus metformin medication.
Treatment:
Other: Exercise training
Metformin group
No Intervention group
Description:
This group received only metformin without any exercise intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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