Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Anne Klibanski, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00140842

First received: August 30, 2005

Last updated: October 3, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

October 3, 2011

Start Date ^ICMJE

May 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak Growth Hormone (GH) on the GH Stimulation Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00140842 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visceral Adipose Tissue [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Official Title ^ICMJE

Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Brief Summary

This study will examine hormonal differences in ghrelin and growth hormone in obese and normal weight adolescents and their relationship to body composition and insulin resistance. The study will also investigate the effect of the macronutrient composition of a meal on postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger and caloric intake at a subsequent meal.

Detailed Description

Obesity is an epidemic that is striking people at younger ages than ever before. Obesity is associated with changes in the secretory patterns of several hormones including ghrelin, growth hormone (GH), and insulin, which have not been examined in the adolescent age group. Ghrelin, a primarily gastric hormone, increases appetite and is a GH secretagogue. This study will compare the alteration in secretion of ghrelin and GH in overweight and normal weight adolescent girls through frequent blood sampling and GH stimulation testing with growth hormone releasing hormone and arginine. The relationship between these hormones and insulin resistance, measured by 1H-nuclear magnetic resonance spectroscopy, and body composition, measured by dual energy x-ray absorptiometry and magnetic resonance imaging, will be investigated. This study will also determine the postprandial ghrelin response to test meals that vary by the type of predominant macronutrient, which may predict the degree of hunger and amount of intake at a subsequent meal. Understanding obesity-related changes in ghrelin and GH and their relationship to body composition, insulin resistance, and appetite will help in the development of strategies to reduce complications of obesity.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Serum and urine collected

Sampling Method

Non-Probability Sample

Study Population

Obese and normal-weight girls between 12-18 years old

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Obese girls
The inclusion criteria will be girls 12-18 years of age. According to the Centers for Disease Control and Prevention, the definition of obesity is a BMI higher than the 95th percentile for age and sex, and that of overweight is a BMI between the 85th and 95th percentiles. Cases will be defined as having a body mass index (BMI) greater than the 95th percentile for age according to the 2000 Centers for Disease Control and Prevention growth charts.
Normal-weight girls

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Girls 12-18 years of age
Obese subjects: BMI higher than the 95th percentile for age and sex
Normal-weight controls: BMI from the 15th to the 85th percentiles for age and sex

Exclusion Criteria:

History of disorders other than obesity that may affect growth hormone, ghrelin, cortisol, or insulin secretion such as eating disorder, diabetes mellitus, hypertension, thyroid disease, Cushing's syndrome, liver disease, renal failure, or an excess or deficiency of GH or cortisol
Medications that could affect glucose and lipid levels or the secretion of growth hormone, ghrelin, insulin, or cortisol such as rhGH, glucocorticoids, and birth control pills
Pregnancy
Smoking or substance abuse
Active dieting
Surgical procedures for obesity
Dietary restrictions such as bread, dairy, peanut, aspartame, or meat products used in the study
Metal implants, including intracranial surgical clips or pacemakers

Gender

Female

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00140842

Other Study ID Numbers ^ICMJE

2004-P-002191

Has Data Monitoring Committee

Responsible Party

Anne Klibanski, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anne Klibanski, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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