- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404624
Characterization of Transcriptional Regulators of Ghrelin Hormone Which Causes Genetic Obesity
July 27, 2011 updated by: Samsung Medical Center
Increased Density of Ghrelin-Expressing Cells in the Gastric Fundus and Body in Prader-Willi Syndrome
The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense and the plasma ghrelin level which increases unusual from the recently PWS patients was discovered.
The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with peptide hormone and the location is 3p26-p25.
Becomes the secretion even from nervous system but from dignity X/A cell it is secreted mainly and growth is important even in the vagal control against food and intake and a dignity function even on the action outside which promotes the secretion which drives it operates.
It increases food intake specially and in order to accomplish the action which diminishes fat utilization the obesity with the week cause which it does the mortar it is thought.
Active the ghrelin of the form is essential in hormonal activity of the ghrelin and appetite and growth hormone it participates to the secretion promotion which drives.
Action of the Ghrelin measuring the quantitative change in middle acylated of the PWS patient ghrelin in order to happen after the acylation initially by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS patient and the blood of the normal army and active ghrelin it measured a change.
Study Overview
Status
Completed
Conditions
Detailed Description
It will reach to respect, in 5 ' -flanking region of the ghrelin 2000 bp focus it let and it got luciferase assay it led and and it searched for the binding it sorted it put out and and to sleep the transcription factor which and and is the possibility of doing the essential region in the transcription and and it did an order deletion clone and and. is important in result and ghrelin activity the region role, -300~-200 region Basic helix-loop-helix (bHLH) are containing -USF (-236 to -231) binding site specially to be compressed in -500~-400 and -300~-200 two portions.
Study Type
Observational
Enrollment (Actual)
58
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
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Sixteen PWS patients [age, 8.1 +- 2.6 yr; 12 males, 4 females; body mass index (BMI), 25+-1.5 kg/m2], 19 healthy normal lean subjects (age, 8.9 +- 1.4 yr; 14 males, 5 females; BMI, 16.5 +- 0.42 kg/m2), 13 GHD patients (age, 9.1 +- 1.8 yr; 9 males, 4 females; BMI, 27 +- 1.8 kg/m2), and 10 healthy normal obese subjects (age, 8.7 +- 2.3 yr; 7 males, 3 females; BMI, 26 +- 1.7 kg/m2) were enrolled in the study.
The subjects had no history of GH treatment and were not being treated with GH at study commencement.
Description
Inclusion Criteria:
- PWS patients were genetically confirmed using the standard methylation test. GHD was diagnosed using a GH stimulation test. The lean and obese normal subjects (comparison group) enrolled were the children or siblings of hospital staff who understood the purpose of and the procedures used.
Exclusion Criteria:
- GHD patients had no history of GH treatment, and were not being treated with GH at study commencement
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
- Observational Models: Case-Control
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dong-Kyu Jin, M.D, Samsung Medical Center, Sungkyunkwan University School of Medicine
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
January 1, 2005
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 27, 2011
First Posted (Estimate)
July 28, 2011
Study Record Updates
Last Update Posted (Estimate)
July 28, 2011
Last Update Submitted That Met QC Criteria
July 27, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Genetic Diseases, Inborn
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Syndrome
- Obesity
- Prader-Willi Syndrome
Other Study ID Numbers
- 2007-01-016
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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