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

August 30, 2005
October 3, 2011
May 2005
June 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00140842 on ClinicalTrials.gov Archive Site
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)
Not Provided
Not Provided
Not Provided
 
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Serum and urine collected

Non-Probability Sample

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

Obesity
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Female
12 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140842
2004-P-002191
No
Anne Klibanski, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2011

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