Skip to main content
Clinical Trials/NCT00140842
NCT00140842
Completed
Not Applicable

Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Massachusetts General Hospital1 site in 1 country47 target enrollmentMay 2005
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Massachusetts General Hospital
Enrollment
47
Locations
1
Primary Endpoint
Peak Growth Hormone (GH) on the GH Stimulation Test
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
June 2007
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Madhusmita Misra

Chief, Pediatric Endocrinology

Massachusetts General Hospital

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Visceral Adipose Tissue(Baseline)

Study Sites (1)

Loading locations...

Similar Trials