Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

NCT ID: NCT00140842

Last Updated: 2021-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity, adolescent, ghrelin, growth hormone, cortisol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Normal-weight girls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Madhusmita Misra

Chief, Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Madhusmita Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 19325538 (View on PubMed)

Misra 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.

Reference Type RESULT
PMID: 18544645 (View on PubMed)

Russell 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.

Reference Type RESULT
PMID: 19435823 (View on PubMed)

Russell 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.

Reference Type RESULT
PMID: 20080853 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.massgeneral.org/an/studies_healthy.htm

Click here for more information about this study: Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-P-002191

Identifier Type: -

Identifier Source: org_study_id