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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Exercise
• Glucose Intolerance
• Metformin
• Pre Diabetes
• Prediabetic State

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