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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Prince Sattam Bin Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Resistance exercise, Aerobic exercise, Metformin, Insulin resistance

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince Sattam bin Abdulaziz University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Resistance exercise group

Aerobic exercise program

Metformin group

Arm 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.

This group has conducted an aerobic exercise program ( 50-70% maxHR, for 40-50 min) thrice weekly for consecutive twelve weeks plus metformin medication.

This group received only metformin without any exercise intervention.

Outcomes

Primary Outcome Measures

Change in Glycated hemoglobin% (HbA1c%)
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.

Secondary Outcome Measures

Fasting blood glucose (FBG)
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)
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.
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.

Full Information

First Posted
August 7, 2021
Last Updated
August 12, 2021
Sponsor
Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05004948
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Resistance exercise, Aerobic exercise, Metformin, Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise group
Arm Type
Active Comparator
Arm 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.
Arm Title
Aerobic exercise program
Arm Type
Active Comparator
Arm 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.
Arm Title
Metformin group
Arm Type
No Intervention
Arm Description
This group received only metformin without any exercise intervention.
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Resistance and aerobic exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glycated hemoglobin% (HbA1c%)
Description
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.
Time Frame
Pre and post 12-week intervention
Secondary Outcome Measure Information:
Title
Fasting blood glucose (FBG)
Description
It was were evaluated before and after study intervention by collecting blood samples after fasting 10 hours overnight.
Time Frame
Pre and post 12-week intervention
Title
homeostatic model assessment of insulin resistance (HOMA-IR)
Description
It was were evaluated before and after study intervention by collecting blood samples after fasting 10-12 hours overnight.
Time Frame
Pre and post 12-week intervention
Title
The maximum oxygen uptake (VO2max)
Description
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.
Time Frame
Pre and post 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Kamal Abdelbasset, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Sattam bin Abdulaziz University
City
Al Kharj
State/Province
Riyadh
ZIP/Postal Code
11942
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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