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NCT05052918 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05052918
Other study ID # EXERCISECIMT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2021
Est. completion date March 15, 2023

Study information
Verified date June 2022
Source Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Contact Elif Yildirim Ayaz, M.D.
Phone +905325148300
Email drelifyildirim@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise
1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks

Locations
Country Name City State
Turkey Sultan Abdülhamid Han Training and Research Hospital Üsküdar Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Carotid ultrasound milimeter size of carotid intima media thickness 12 weeks
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