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Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00140842
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : September 2, 2011
Last Update Posted : October 7, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

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 Design

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Study Start Date : May 2005
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Peak Growth Hormone (GH) on the GH Stimulation Test [ Time Frame: Baseline ]
    Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.

Secondary Outcome Measures :
  1. Visceral Adipose Tissue [ Time Frame: Baseline ]
    Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)

Biospecimen Retention:   Samples Without DNA
Serum and urine collected

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese and normal-weight girls between 12-18 years old

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. 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
  3. Pregnancy
  4. Smoking or substance abuse
  5. Active dieting
  6. Surgical procedures for obesity
  7. Dietary restrictions such as bread, dairy, peanut, aspartame, or meat products used in the study
  8. Metal implants, including intracranial surgical clips or pacemakers
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140842

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
More Information

Responsible Party: Anne Klibanski, MD, Laurie Carrol Guthart Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00140842     History of Changes
Other Study ID Numbers: 2004-P-002191
First Posted: September 1, 2005    Key Record Dates
Results First Posted: September 2, 2011
Last Update Posted: October 7, 2011
Last Verified: September 2011

Keywords provided by Anne Klibanski, MD, Massachusetts General Hospital:
Obesity, adolescent, ghrelin, growth hormone, cortisol

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms