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

Not Applicable

• Conditions: Exercise; Metformin; Pre Diabetes; Atherosclerosis
• Interventions: Behavioral: Exercise

• Registration Number: NCT05052918
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-07
• Study Start: 2021-09-08
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-22
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Patients with prediabetes undergoing a 12-week exercise program (1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)

Primary Outcome Measures

Name	Time	Method
Carotid ultrasound	12 weeks	milimeter size of carotid intima media thickness

Trial Locations

Locations (1)

Sultan Abdülhamid Han Training and Research Hospital; 🇹🇷 Üsküdar, İstanbul, Turkey