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

NCT ID: NCT05052918

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2023-03-15

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.

Conditions

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Pre Diabetes Exercise Metformin Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Patients with prediabetes undergoing a 12-week exercise program

(1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks

Control

Patients with prediabetes with no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Metformin

Patients with prediabetes using metformin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elif Yıldırım Ayaz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sultan Abdülhamid Han Training and Research Hospital

Locations

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Sultan Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif Yıldırım Ayaz, M.D.

Role: CONTACT

+905325148300

Emine Şeyma Denli Yalvaç, M.D.

Role: CONTACT

+905057311317

Facility Contacts

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Elif Yıldırım Ayaz, M.D.

Role: primary

+905325148300

Emine Şeyma Denli Yalvaç, M.D.

Role: backup

+905057311317

Other Identifiers

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EXERCISECIMT

Identifier Type: -

Identifier Source: org_study_id

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