ObesityNCT00140842
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
An observational study of Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Obese and normal-weight girls between 12-18 years old
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, adolescent, ghrelin, growth hormone, cortisol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Visceral Adipose Tissue
Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhusmita Misra, Massachusetts General Hospital
- Investigators
- Madhusmita Misra, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140842
- Sponsor's protocol ID
- 2004-P-002191
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2005
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19325538Misra 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.
PubMed 18544645Russell 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.
PubMed 19435823Russell 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.
PubMed 20080853
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT00140842
- Acronym / sponsor ID
- 2004-P-002191
- Conditions
- Obesity
- Keywords
- Obesity, adolescent, ghrelin, growth hormone, cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Obese and normal-weight girls between 12-18 years old
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak Growth Hormone (GH) on the GH Stimulation Test
Time frame: Baseline
Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.
1 secondary outcome
Visceral Adipose Tissue
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19325538Misra 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.
- Results publication: PubMed 18544645Misra 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.
- Results publication: PubMed 19435823Russell 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.
- Results publication: PubMed 20080853Russell 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.
- Click here for more information about this study: Neuroendocrine Modulation of Metabolic Effects in Overweight AdolescentsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhusmita Misra, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Growth Hormone (GH) on the GH Stimulation Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140842, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.