Effect of Exercise on GDF-15 Levels in Prediabetic Patients
1 other identifier
interventional
70
1 country
1
Brief Summary
The aim of this study is to evaluate whether there is a change in GDF-15 levels in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program with guide-based exercise programs.
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 Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJune 22, 2022
June 1, 2022
2 years
March 7, 2021
June 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of Growth Diferantiation Factor-15
Level of Growth Diferantiation Factor-15
12 weeks
Secondary Outcomes (1)
Level of VO2max
12 weeks
Study Arms (3)
İntevention group
ACTIVE COMPARATORPrediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made.
Control group
NO INTERVENTIONPrediabetic patients with age 30-50 and overweight Only Standart recommendations
Metformin Group
NO INTERVENTIONPrediabetic patients who received metformin Standart recommendations
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index 30-34.9 kg / m2
- Sedentary life-style (Physical activity below 300 kcal / day will be assessed by Minnesota Leisure Physical Activity Questionnaire)
- Those who have sufficient motivation to participate in the exercise program (will be evaluated by face-to-face interview by the researchers)
- Having 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 will be included.
You may not qualify if:
- Serious medical condition (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having cardiovascular disease
- Having diabetes
- Using metformin
- Taking hormone replacement therapy
- less than 1 year life expectancy
- HIV positivity
- Substance use
- Functional dependence
- Cognitive weakness
- Those with other diseases that will affect the study result (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
Istanbul, 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 Rsearch Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2021
First Posted
March 16, 2021
Study Start
April 15, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06