Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity

NCT00562796 | Completed

• 2 other identifiers: 5551R01HL085268-01A1
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Growth Hormone

Keywords

Growth Hormone Deficiency; Cardiovascular Disease; Intra-abdominal Fat; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Prevalence of growth hormone deficiency

  Measured at baseline

Secondary Outcomes (1)

• Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines

  Measured at baseline

Study Arms (3)

1

Participants with abdominal obesity without growth hormone deficiency

2

Participants with abdominal obesity with growth hormone deficiency

3

Participants who are lean controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• Stanley TL, Feldpausch MN, Murphy CA, Grinspoon SK, Makimura H. Discordance of IGF-1 and GH stimulation testing for altered GH secretion in obesity. Growth Horm IGF Res. 2014 Feb;24(1):10-5. doi: 10.1016/j.ghir.2013.11.001. Epub 2013 Nov 15.

  PMID: 24291224 DERIVED

• Makimura H, Feldpausch MN, Stanley TL, Sun N, Grinspoon SK. Reduced growth hormone secretion in obesity is associated with smaller LDL and HDL particle size. Clin Endocrinol (Oxf). 2012 Feb;76(2):220-7. doi: 10.1111/j.1365-2265.2011.04195.x.

  PMID: 21819438 DERIVED

• Makimura H, Stanley TL, Sun N, Connelly JM, Hemphill LC, Hrovat MI, Systrom DM, Grinspoon SK. Increased skeletal muscle phosphocreatine recovery after sub-maximal exercise is associated with increased carotid intima-media thickness. Atherosclerosis. 2011 Mar;215(1):214-7. doi: 10.1016/j.atherosclerosis.2010.11.037. Epub 2010 Dec 5.

  PMID: 21185022 DERIVED

• Makimura H, Stanley TL, Sun N, Connelly JM, Hemphill LC, Grinspoon SK. The relationship between reduced testosterone, stimulated growth hormone secretion and increased carotid intima-media thickness in obese men. Clin Endocrinol (Oxf). 2010 Nov;73(5):622-9. doi: 10.1111/j.1365-2265.2010.03859.x.

  PMID: 20681993 DERIVED

• Makimura H, Stanley T, Mun D, Chen C, Wei J, Connelly JM, Hemphill LC, Grinspoon SK. Reduced growth hormone secretion is associated with increased carotid intima-media thickness in obesity. J Clin Endocrinol Metab. 2009 Dec;94(12):5131-8. doi: 10.1210/jc.2009-1295. Epub 2009 Oct 16.

  PMID: 19837914 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity; Dwarfism, Pituitary; Cardiovascular Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Steven K. Grinspoon, MD

  Program in Nutritional Metabolism, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2011
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

US (1)