The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedStudy Start
First participant enrolled
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedJune 22, 2022
June 1, 2022
1.5 years
September 7, 2021
June 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotid ultrasound
milimeter size of carotid intima media thickness
12 weeks
Study Arms (3)
Exercise
ACTIVE COMPARATORPatients with prediabetes undergoing a 12-week exercise program (1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)
Control
NO INTERVENTIONPatients with prediabetes with no intervention
Metformin
NO INTERVENTIONPatients with prediabetes using metformin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Abdülhamid Han Training and Research Hospital
Üsküdar, Istanbul, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elif Yıldırım Ayaz, M.D.
Sultan Abdülhamid Han Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 22, 2021
Study Start
September 8, 2021
Primary Completion
March 15, 2023
Study Completion
March 15, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06