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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong-Kyu Jin, M.D, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-01-016

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