NCT05004948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 7, 2021

Last Update Submit

August 12, 2021

Conditions

Type 2 Diabetes

Keywords

Resistance exerciseAerobic exerciseMetforminInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Fasting blood glucose (FBG)

    Pre and post 12-week intervention

  • homeostatic model assessment of insulin resistance (HOMA-IR)

    Pre and post 12-week intervention

  • The maximum oxygen uptake (VO2max)

    Pre and post 12-week intervention

Study Arms (3)

Resistance exercise group

ACTIVE COMPARATOR

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.

Other: Exercise training

Aerobic exercise program

ACTIVE COMPARATOR

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

Other: Exercise training

Metformin group

NO INTERVENTION

This group received only metformin without any exercise intervention.

Interventions

Exercise trainingOTHER

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.

Also known as: Resistance and aerobic exercise program
Aerobic exercise programResistance exercise group

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Cancer
  • Pregnancy
  • Corticosteroid medications
  • Uncontrolled systemic diseases
  • Any physical limits that affect exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Walid Kamal Abdelbasset, PhD

    Prince Sattam Bin Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 13, 2021

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

October 15, 2019

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)