The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Primary Purpose
Pre Diabetes, Exercise, Metformin
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pre Diabetes focused on measuring Prediabetes, exercise, metformin, atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Sultan Abdülhamid Han Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Exercise
Control
Metformin
Arm Description
Patients with prediabetes undergoing a 12-week exercise program (1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)
Patients with prediabetes with no intervention
Patients with prediabetes using metformin
Outcomes
Primary Outcome Measures
Carotid ultrasound
milimeter size of carotid intima media thickness
Secondary Outcome Measures
Full Information
NCT ID
NCT05052918
First Posted
September 7, 2021
Last Updated
June 19, 2022
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05052918
Brief Title
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Official Title
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Exercise, Metformin, Atherosclerosis
Keywords
Prediabetes, exercise, metformin, atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Patients with prediabetes undergoing a 12-week exercise program
(1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients with prediabetes with no intervention
Arm Title
Metformin
Arm Type
No Intervention
Arm Description
Patients with prediabetes using metformin
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks
Primary Outcome Measure Information:
Title
Carotid ultrasound
Description
milimeter size of carotid intima media thickness
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Şeyma Denli Yalvaç, M.D.
Phone
+905057311317
Email
seymadenli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Organizational Affiliation
Sultan Abdülhamid Han Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdülhamid Han Training and Research Hospital
City
Üsküdar
State/Province
İstanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
First Name & Middle Initial & Last Name & Degree
Emine Şeyma Denli Yalvaç, M.D.
Phone
+905057311317
Email
seymadenli@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
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