Effect of Exercise on GDF-15 Levels in Prediabetic Patients

June 19, 2022 updated by: Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Sultan Abdulhamid Han Training and Research Hospital
        • Contact:
          • Elif Yıldırım Ayaz, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: İntevention group
Prediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made.
Behavioral: Exercise
180 minutes of moderate-intensity exercise per week
No Intervention: Control group
Prediabetic patients with age 30-50 and overweight Only Standart recommendations
No Intervention: Metformin Group
Prediabetic patients who received metformin Standart recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Growth Diferantiation Factor-15
Time Frame: 12 weeks
Level of Growth Diferantiation Factor-15
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of VO2max
Time Frame: 12 weeks
Level of VO2max
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Elif Yıldırım Ayaz, M.D., Sultan Abdülhamid Han Training and Rsearch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTİVE GD-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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