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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre Diabetes, Exercise, Metformin, Atherosclerosis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>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<br>* 1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks<br>|
| No Intervention: Control<br>Patients with prediabetes with no intervention | |
| No Intervention: Metformin<br>Patients with prediabetes using metformin | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, exercise, metformin, atherosclerosis