GhrelinNCT04447391
Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls
A study testing Combined exercise program in people with Ghrelin, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls. Read more about this study
- Who is it for?
- Ages 16 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ghrelin
- What is being tested?
- Combined exercise program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2015to 31 Dec 2015
- 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 16 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- girls between 16 and 18 years
- being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2-18 years.
- After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.
Who cannot join
- participation in any weight-management programme in the past 6 months
- engagement in other exercise programs except for regular physical education at school
- smoking
- amenorrhea for consecutive 2 months or more
- being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
- taking any medication or supplements for weight control
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Effects of a 12-week Combined Exercise Program on Acylated and Desacyl Ghrelin, and Ghrelin O Acyl Transferase in Obese Adolescent Girls
This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.
Read the detailed description
Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our previous study showed that combined exercise program in overweight children increases DAG with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on GOAT, AG, and DAG in obese girls.
- Conditions
- Ghrelin
- Being tested
- Combined exercise program, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise programOther
Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet
ControlOther
300 kcal deficit diet only
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks. Receives: Other: Combined exercise program |
| Control group | Placebo comparator | Control group who performed 300 kcal/day deficit diet during 12 weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
body fat percent
Changes in body fat percent during 12 weeks
Measured: Change from baseline body fat percent at 12 weeks
acylated ghrelin
Changes in concentrations of acylated ghrelin during 12 weeks
Measured: Change from concentrations of baseline acylated ghrelin at 12 weeks
desacylated ghrelin
Changes in concentrations of desacylated ghrelin during 12 weeks
Measured: Change from concentrations of baseline desacylated ghrelin at 12 weeks
Secondary outcomes (1)
ghrelin O acyl transferase
Changes in concentrations of ghrelin O acyl transferase during 12 weeks
Measured: Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start10 Sep 2015
- Primary completion30 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GhrelinStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447391
- Sponsor's protocol ID
- 04-2015-015
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Combined Exercise Program on Acylated and Desacyl Ghrelin, and Ghrelin O Acyl Transferase in Obese Adolescent Girls
- ClinicalTrials.gov ID
- NCT04447391
- Acronym / sponsor ID
- 04-2015-015
- Conditions
- Ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 25 Jun 2020 (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.
This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.
Detailed description
Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our previous study showed that combined exercise program in overweight children increases DAG with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on GOAT, AG, and DAG in obese girls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Combined exercise programExercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks. |
| Control group | Placebo comparator | Other: ControlControl group who performed 300 kcal/day deficit diet during 12 weeks. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- girls between 16 and 18 years
- being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2-18 years.
- After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.
Key exclusion criteria (6 listed)
- participation in any weight-management programme in the past 6 months
- engagement in other exercise programs except for regular physical education at school
- smoking
- amenorrhea for consecutive 2 months or more
- being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
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 |
|---|---|---|
| Combined exercise programCombined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet | Other | Exercise group |
| Control300 kcal deficit diet only | Other | Control group |
Primary outcome
body fat percent
Time frame: Change from baseline body fat percent at 12 weeks
Changes in body fat percent during 12 weeks
acylated ghrelin
Time frame: Change from concentrations of baseline acylated ghrelin at 12 weeks
Changes in concentrations of acylated ghrelin during 12 weeks
desacylated ghrelin
Time frame: Change from concentrations of baseline desacylated ghrelin at 12 weeks
Changes in concentrations of desacylated ghrelin during 12 weeks
1 secondary outcome
ghrelin O acyl transferase
Time frame: Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan 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 Combined exercise program in people with Ghrelin, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jun 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body fat percent (time frame: Change from baseline body fat percent at 12 weeks). The study lists 3 primary outcomes in all. 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 26 Jun 2020.