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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status: Enrolling

Conditions: Metformin; Pre Diabetes; Atherosclerosis; Exercise

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05052918

EXERCISECIMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

Patients with prediabetes with no intervention

Metformin

No Intervention group

Description:

Patients with prediabetes using metformin