N/A
N=30
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00140842 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Peak Growth Hormone (GH) on the GH Stimulation Test — 40.1; 25.2 ng/ml — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Growth Hormone (GH) on the GH Stimulation Test |
40.1; 25.2 | <0.05 sig |
| SECONDARY Visceral Adipose Tissue |
19; 42.7 | <0.05 sig |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT00140842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.