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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004948
• Other study ID #: RHPT/018/029
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: August 2021
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 15, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Exercise training
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.

Locations

Country	Name	City	State
Saudi Arabia	Prince Sattam bin Abdulaziz University	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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