Clinical trial NCT05004948: Exercise Intervention Combined With Metformin in the Treatment of Type 2 Diabetes
Official title: Resistance Exercise Versus Aerobic Exercise Combined With Metformin Therapy in the Treatment of Type 2 Diabetes: A 12-Week Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Resistance exercise
Aerobic exercise
Metformin
Insulin resistance
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycated hemoglobin% (HbA1c%)
timeFrame: Pre and post 12-week intervention
Secondary outcomes:
measure: Fasting blood glucose (FBG)
timeFrame: Pre and post 12-week intervention
measure: homeostatic model assessment of insulin resistance (HOMA-IR)
timeFrame: Pre and post 12-week intervention
measure: The maximum oxygen uptake (VO2max)
timeFrame: Pre and post 12-week intervention
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Prince Sattam bin Abdulaziz University
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Walid Kamal Abdelbasset, PhD
role: PRINCIPAL_INVESTIGATOR
References: