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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Adipose Tissue | Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Obese and normal-weight girls between 12-18 years old
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| Name | Affiliation | Role |
|---|---|---|
| Madhusmita Misra, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19325538 | Result | 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. | |
| 18544645 | Result | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study: Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents | View source |
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17 obese and 30 normal-weight adolescents (12-18 yr old) were screened for study eligibility.15 obese adolescents completed the study visit. These subjects were matched for race, ethnicity, and bone age to normal-weight adolescents from the pool of screened subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal-weight Girls | Normal weight girls 12-18 years old |
| FG001 | Obese Girls | Obese adolescents between 12-18 years old. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal-weight Girls | Normal-weight girls were required to have a BMI between the 15th-85th percentiles |
| BG001 | Obese Girls | Obese girls were required to have a BMI above the 95th percentile |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal-weight Girls | Normal-weight girls were required to have a BMI between the 15th-85th percentiles |
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Limited number of participants-pilot study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhu Misra, MD | Massachusetts General Hospital | 617-724-5602 | mmisra@partners.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Serum and urine collected
| 19435823 | Result | 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. |
| 20080853 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Visceral Adipose Tissue | Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4) | The analysis was completed on the 30 participants as per protocol | Posted | Mean | Standard Deviation | grams | Baseline |
|
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|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Obese Girls | Obese girls were required to have a BMI above the 95th percentile | 0 | 15 | 0 | 15 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |