- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447391
Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls
June 24, 2020 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
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
-
-
Gyeungsangnam-do
-
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
-
-
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
16 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Exercise group who performed a combined exercise and 300 kcal/day deficit diet during 12 weeks.
|
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
|
|
Placebo Comparator: Control group
Control group who performed 300 kcal/day deficit diet during 12 weeks.
|
300 kcal deficit diet only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body fat percent
Time Frame: Change from baseline body fat percent at 12 weeks
|
Changes in body fat percent during 12 weeks
|
Change from baseline body fat percent at 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
|
Change from concentrations of baseline acylated ghrelin at 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
|
Change from concentrations of baseline desacylated ghrelin at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ghrelin O acyl transferase
Time Frame: Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
|
Changes in concentrations of ghrelin O acyl transferase during 12 weeks
|
Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 10, 2015
Primary Completion (Actual)
December 30, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 25, 2020
Study Record Updates
Last Update Posted (Actual)
June 26, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 04-2015-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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