The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes

June 19, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey, 34668
        • Recruiting
        • Sultan Abdülhamid Han Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Leading a sedentary life
  • Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
  • Have the same weight for 6 months before participating in the study (±2.5 kg)
  • Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement

Exclusion Criteria:

  • Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
  • Having cardiovascular disease
  • Being diabetic
  • Using metformin before participating in the study
  • Receiving hormone replacement therapy
  • Life expectancy less than 1 year
  • HIV positivity
  • Substance use
  • Functional dependency
  • Cognitive weakness
  • Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)
  • Those who use drugs or supplements that will affect the results of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise

Patients with prediabetes undergoing a 12-week exercise program

(1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)
Behavioral: Exercise
1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks
No Intervention: Control
Patients with prediabetes with no intervention
No Intervention: Metformin
Patients with prediabetes using metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid ultrasound
Time Frame: 12 weeks
milimeter size of carotid intima media thickness
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 12, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXERCISECIMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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