Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00562796
First received: November 21, 2007
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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
Obesity
Growth Hormone

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Prevalence of growth hormone deficiency [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples will include serum, plasma, whole blood, and white blood cells


Enrollment: 149
Study Start Date: November 2007
Study Completion Date: May 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants with abdominal obesity without growth hormone deficiency
2
Participants with abdominal obesity with growth hormone deficiency
3
Participants who are lean controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562796

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven K. Grinspoon, MD Program in Nutritional Metabolism, Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional 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, 1R01-HL85268-01A1
Study First Received: November 21, 2007
Last Updated: August 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Growth Hormone Deficiency
Cardiovascular Disease
Intra-abdominal Fat
Insulin Resistance

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

ClinicalTrials.gov processed this record on October 22, 2014