Effect of Exercise on GDF-15 Levels in Prediabetic Patients

PreDiabetes Clinical Trial

Official title:

Effect of Exercise on GDF-15 Levels in Prediabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799938
• Other study ID #: ACTIVE GD-15
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2022
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Elif Yildirim Ayaz, M.D.
• Phone: +905325148300
• Email: drelifyildirim[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

GDF-15, which has anorexigenic effects, increases with exercise. In prediabetic patients, GDF-15 is higher than healthy controls. The effect of exercise on GDF-15 levels in prediabetic patients is unknown. The aim of this study is to evaluate whether there is a change in GDF-15 levels after the application of guideline-based exercise programs in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Exercise
180 minutes of moderate-intensity exercise per week

Locations

Country	Name	City	State
Turkey	Sultan Abdülhamid Han Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Growth Diferantiation Factor-15	Level of Growth Diferantiation Factor-15	12 weeks
Secondary	Level of VO2max	Level of VO2max	12 weeks