Growth Hormone, Cardiovascular Risk, and Visceral Adiposity in Women - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00131378

Purpose

This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women. In women with increased abdominal weight, growth hormone (GH) will be given and effects on cardiovascular risk and body composition will be measured.

Condition	Intervention
Obesity	Drug: Nutropin AQ growth hormone Drug: Placebo Growth Hormone

MedlinePlus related topics: Obesity

Drug Information available for: Insulin Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Growth Hormone, Cardiovascular Risk, and Visceral Adiposity in Women

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

24-hour growth hormone secretion [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
GH stimulation peak [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
Body composition and cardiovascular risk markers [ Time Frame: Measured at baseline and Months 1, 3, 6, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose and insulin levels [ Time Frame: Measured at baseline and Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
Insulin-like growth factor-I (IGFI) levels [ Time Frame: Measured at baseline and Months 1, 2, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
Nutritional status, exercise, weight, waist and hip circumferences, and resting energy expenditure [ Time Frame: Measured at baseline and Months 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	November 2004
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive growth hormone replacement therapy.	Drug: Nutropin AQ growth hormone Participants will give themselves injections of growth hormone every night for 6 months.
2: Placebo Comparator Participants will receive placebo.	Drug: Placebo Growth Hormone Participants will give themselves injections of placebo growth hormone every night for 6 months.

Detailed Description:

The purpose of this study is to measure growth hormone levels in women of normal weight, overweight, and overweight with increased visceral adiposity. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women with increased visceral adiposity and below average growth hormone levels, growth hormone will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

For growth hormone measurement part:
1. For visceral adiposity arm: waist circumference greater than or equal to 88 cm and BMI greater than or equal to 25 kg/m2
2. For lean controls: BMI 18.5 to 24.9 kg/m2
For growth hormone treatment part:
1. Visceral adiposity (waist circumference greater than or equal to 88 cm, BMI greater than or equal to 25 kg/m2)
2. IGF-I within the lowest 2 quartiles for age and gender
3. Willingness to maintain current activity level and diet

Exclusion Criteria:

Diabetes mellitus (fasting plasma glucose greater than 126 mg/dL or 2-hour post-oral glucose tolerance test [OGTT] plasma glucose greater than 200)
Taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight
Smoking
Hematocrit below the lower limit of normal
Amenorrhea for 3 months
Pregnant or breastfeeding
Polycystic ovary syndrome
Weight that exceeds 280 pounds
SGPT greater than 2 times the upper limit of normal
History of malignancy, except for fully resolved basal cell carcinomas of the skin (Specific Aim 2 only)
Radiation exposure greater than 1000 mrem over the last 12 months
Previous diagnosis of cardiovascular disease
History of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency
History of carpal tunnel syndrome that has not been surgically treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131378

Contacts

Contact: Danielle Brick	617-724-0785	Dbrick@partners.org
Contact: Karen K. Miller, MD	617-726-3870

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Danielle Brick 617-724-0785 Dbrick@partners.org
Contact: Karen K. Miller, MD 617-726-3870

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Karen K. Miller, MD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Karen K. Miller, MD )
Study ID Numbers:	525, MGH GCRC 678, 2004-P-000013
Study First Received:	August 16, 2005
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00131378
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Visceral obesity
Growth hormone
Cardiovascular risk
Insulin resistance

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Insulin Resistance
Insulin

ClinicalTrials.gov processed this record on January 16, 2009