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Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00140842
Enrollment
47
Registered
2005-09-01
Start date
2005-05-31
Completion date
2007-06-30
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, adolescent, ghrelin, growth hormone, cortisol

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak Growth Hormone (GH) on the GH Stimulation TestBaselinePeak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.

Secondary

MeasureTime frameDescription
Visceral Adipose TissueBaselineVisceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Normal-weight Girls
Normal-weight girls were required to have a BMI between the 15th-85th percentiles
15
Obese Girls
Obese girls were required to have a BMI above the 95th percentile
15
Total30

Baseline characteristics

CharacteristicNormal-weight GirlsObese GirlsTotal
Age, Categorical
<=18 years
15 Participants15 Participants30 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous15.9 years
STANDARD_DEVIATION 1.7
14.0 years
STANDARD_DEVIATION 1.9
14.9 years
STANDARD_DEVIATION 3.3
Sex: Female, Male
Female
15 Participants15 Participants30 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

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.

Time frame: Baseline

Population: 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

ArmMeasureValue (MEAN)Dispersion
Normal-weight GirlsPeak Growth Hormone (GH) on the GH Stimulation Test40.1 ng/mlStandard Deviation 16.1
Obese GirlsPeak Growth Hormone (GH) on the GH Stimulation Test25.2 ng/mlStandard Deviation 21.8
Comparison: The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.p-value: <0.05t-test, 2 sided
Secondary

Visceral Adipose Tissue

Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)

Time frame: Baseline

Population: The analysis was completed on the 30 participants as per protocol

ArmMeasureValue (MEAN)Dispersion
Normal-weight GirlsVisceral Adipose Tissue19 gramsStandard Deviation 7.5
Obese GirlsVisceral Adipose Tissue42.7 gramsStandard Deviation 17
Comparison: The null hypothesis is that there is no difference between the groups for visceral adipose tissuep-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026