PreDiabetesNCT04799938
Effect of Exercise on GDF-15 Levels in Prediabetic Patients
A study testing Exercise in people with PreDiabetes, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Training and Research Hospital
Istanbul
Elif Yıldırım Ayaz, M.D.
About this study
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Exercise
- Keywords
- GDF-15, Physical Exercise, Prediabetes
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
180 minutes of moderate-intensity exercise per week
| Study group | Role | What they receive |
|---|---|---|
| İntevention group | Active comparator | Prediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made. Receives: Behavioral: Exercise |
| Control group | No intervention | Prediabetic patients with age 30-50 and overweight Only Standart recommendations |
| Metformin Group | No intervention | Prediabetic patients who received metformin Standart recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Growth Diferantiation Factor-15
Level of Growth Diferantiation Factor-15
Measured: 12 weeks
Secondary outcomes (1)
Level of VO2max
Level of VO2max
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise intervention will be applied to intervention group All participiants will be applied to standard recommendations
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Han Training and Rsearch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799938
- Sponsor's protocol ID
- ACTİVE GD-15
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on GDF-15 Levels in Prediabetic Patients
- ClinicalTrials.gov ID
- NCT04799938
- Acronym / sponsor ID
- ACTİVE GD-15
- Conditions
- PreDiabetes
- Keywords
- GDF-15, Physical Exercise, Prediabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Exercise intervention will be applied to intervention group All participiants will be applied to standard recommendations
| Arm | Type | Receives |
|---|---|---|
| İntevention group | Active comparator | Behavioral: ExercisePrediabetic patients with age 30-50 and overweight Standart recommendations Exercise intervention will be made. |
| Control group | No intervention | –Prediabetic patients with age 30-50 and overweight Only Standart recommendations |
| Metformin Group | No intervention | –Prediabetic patients who received metformin Standart recommendations |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise180 minutes of moderate-intensity exercise per week | Behavioural | İntevention group |
Primary outcome
Level of Growth Diferantiation Factor-15
Time frame: 12 weeks
Level of Growth Diferantiation Factor-15
1 secondary outcome
Level of VO2max
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yıldırım Ayaz, M.D. principal investigator
Sultan Abdülhamid Han Training and Rsearch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with PreDiabetes, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Yıldırım Ayaz, M.D. (+905325148300, drelifyildirim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Growth Diferantiation Factor-15 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.