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Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity

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ClinicalTrials.gov Identifier: NCT00562796
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : August 23, 2011
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Brief Summary:
Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.

Condition or disease
Obesity Growth Hormone

Detailed Description:

Obesity is associated with significant morbidity and mortality and is a primary public health concern. Both the incidence and prevalence of obesity have increased over the last several decades, with obesity now affecting an estimated 31% of the American population. Recent data suggest that people with abdominal obesity commonly exhibit low levels of GH, which affects the body's growth rate and the way the body uses food for energy. Low GH levels and excess abdominal fat have been linked to improper functioning of the cardiovascular system and, therefore, may increase one's risk of cardiovascular disease. This study will determine the prevalence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.

Participation in this observational study will last between 2 and 4 weeks. The study will consist of two outpatient visits, held at either the Massachusetts General Hospital or Massachusetts Institute of Technology. Visit 1 will last 4 hours and will include a physical exam, medical history, blood draw, urine sampling, indirect calorimetry test, and growth hormone releasing hormone (GHRH)+Arginine stimulation test. Eligible participants will return within the next 3 weeks for Visit 2, which will last 5 hours. Before the second visit, participants will be asked to record their food intake for 4 days on a food record. During the visit, participants will have a repeat physical exam, urine sampling, and blood draw. Participants will also undergo an oral glucose tolerance test, whole body DEXA scan, abdominal computed tomography (CT) scan, and a carotid ultrasound. Participation in the study will end after Visit 2.

Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity
Study Start Date : November 2007
Primary Completion Date : December 2009
Study Completion Date : May 2011

Participants with abdominal obesity without growth hormone deficiency
Participants with abdominal obesity with growth hormone deficiency
Participants who are lean controls

Primary Outcome Measures :
  1. Prevalence of growth hormone deficiency [ Time Frame: Measured at baseline ]

Secondary Outcome Measures :
  1. Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines [ Time Frame: Measured at baseline ]

Biospecimen Retention:   Samples With DNA
Samples will include serum, plasma, whole blood, and white blood cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include participants from the community at large who are able to come to either the Massachusetts General Hospital (MGH) Weight Center or Massachusetts Institute of Technology for study visits.

Inclusion Criteria for Obesity:

  • Body mass index (BMI) greater than or equal to 30 kg/m2
  • Abdominal obesity, defined as waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women

Inclusion Criteria for Lean Controls:

  • BMI less than 25 kg/m2
  • Waist circumference less than 102 cm in men and less than 88 cm in women

Exclusion Criteria for both groups:

  • Obesity due to known secondary causes
  • Taking any weight lowering drugs
  • Previous bariatric surgery
  • Use of the following compounds within the 3 months prior to study entry: estrogen, progesterone, GH, GHRH, glucocorticoids, megesterol acetate, antidiabetic agents, oral contraceptive pills, or any other hormone or drug known to affect GH levels
  • Change in lipid lowering or antihypertensive regimen within 3 months prior to study entry
  • Use of testosterone or hormone replacement therapy
  • Previously known diabetes mellitus or other severe chronic illness
  • Hemoglobin less than 11.0 g/dL, creatinine greater than 1.5 mg/dL, or serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times the upper limit of normal
  • Follicle stimulating hormone (FSH) greater than 20 IU/L in women
  • Positive urine pregnancy test
  • Prior history of pituitary disease, pituitary surgery, head irradiation, or any other condition known to affect the GH axis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562796

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Steven K. Grinspoon, MD Program in Nutritional Metabolism, Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00562796     History of Changes
Other Study ID Numbers: 555
1R01HL085268-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
Growth Hormone Deficiency
Cardiovascular Disease
Intra-abdominal Fat
Insulin Resistance

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Obesity, Abdominal
Nutrition Disorders
Body Weight
Signs and Symptoms
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs