Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
1 other identifier
observational
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
September 2, 2011
CompletedNovember 2, 2021
October 1, 2021
2.1 years
August 30, 2005
March 3, 2011
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Growth Hormone (GH) on the GH Stimulation Test
Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.
Baseline
Secondary Outcomes (1)
Visceral Adipose Tissue
Baseline
Study Arms (2)
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
Eligibility Criteria
Obese and normal-weight girls between 12-18 years old
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (4)
Misra M, Tsai PM, Mendes N, Miller KK, Klibanski A. Increased carbohydrate induced ghrelin secretion in obese vs. normal-weight adolescent girls. Obesity (Silver Spring). 2009 Sep;17(9):1689-95. doi: 10.1038/oby.2009.86. Epub 2009 Mar 26.
PMID: 19325538RESULTMisra M, Bredella MA, Tsai P, Mendes N, Miller KK, Klibanski A. Lower growth hormone and higher cortisol are associated with greater visceral adiposity, intramyocellular lipids, and insulin resistance in overweight girls. Am J Physiol Endocrinol Metab. 2008 Aug;295(2):E385-92. doi: 10.1152/ajpendo.00052.2008. Epub 2008 Jun 10.
PMID: 18544645RESULTRussell M, Bredella M, Tsai P, Mendes N, Miller KK, Klibanski A, Misra M. Relative growth hormone deficiency and cortisol excess are associated with increased cardiovascular risk markers in obese adolescent girls. J Clin Endocrinol Metab. 2009 Aug;94(8):2864-71. doi: 10.1210/jc.2009-0380. Epub 2009 May 12.
PMID: 19435823RESULTRussell M, Mendes N, Miller KK, Rosen CJ, Lee H, Klibanski A, Misra M. Visceral fat is a negative predictor of bone density measures in obese adolescent girls. J Clin Endocrinol Metab. 2010 Mar;95(3):1247-55. doi: 10.1210/jc.2009-1475. Epub 2010 Jan 15.
PMID: 20080853RESULT
Related Links
Biospecimen
Serum and urine collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limited number of participants-pilot study
Results Point of Contact
- Title
- Madhu Misra, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Madhusmita Misra, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pediatric Endocrinology
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
May 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
November 2, 2021
Results First Posted
September 2, 2011
Record last verified: 2021-10