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Effect of Exercise on GDF-15 Levels in Prediabetic Patients

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring GDF-15, Physical Exercise, Prediabetes

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

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

İntevention group

Control group

Metformin Group

Arm Description

Prediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made.

Prediabetic patients with age 30-50 and overweight Only Standart recommendations

Prediabetic patients who received metformin Standart recommendations

Outcomes

Primary Outcome Measures

Level of Growth Diferantiation Factor-15
Level of Growth Diferantiation Factor-15

Secondary Outcome Measures

Level of VO2max
Level of VO2max

Full Information

First Posted
March 7, 2021
Last Updated
June 19, 2022
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04799938
Brief Title
Effect of Exercise on GDF-15 Levels in Prediabetic Patients
Official Title
Effect of Exercise on GDF-15 Levels in Prediabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
GDF-15, Physical Exercise, Prediabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exercise intervention will be applied to intervention group All participiants will be applied to standard recommendations
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
İntevention group
Arm Type
Active Comparator
Arm Description
Prediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Prediabetic patients with age 30-50 and overweight Only Standart recommendations
Arm Title
Metformin Group
Arm Type
No Intervention
Arm Description
Prediabetic patients who received metformin Standart recommendations
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
180 minutes of moderate-intensity exercise per week
Primary Outcome Measure Information:
Title
Level of Growth Diferantiation Factor-15
Description
Level of Growth Diferantiation Factor-15
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Level of VO2max
Description
Level of VO2max
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Organizational Affiliation
Sultan Abdülhamid Han Training and Rsearch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdülhamid Han Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.

12. IPD Sharing Statement

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Effect of Exercise on GDF-15 Levels in Prediabetic Patients

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