Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00131378
First received: August 16, 2005
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Nutropin AQ growth hormone Drug: Placebo Growth Hormone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Growth Hormone, Cardiovascular Risk, and Visceral Adiposity |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
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, 6 weeks, and months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measures of insulin resistance [ Time Frame: Measured at baseline, 6 weeks, and months 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
- Insulin-like growth factor-I (IGFI) levels [ Time Frame: Measured at baseline, weeks 3, 6, 9, and months 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
- Nutritional status, exercise, weight, waist and hip circumferences, and resting energy expenditure [ Time Frame: Measured at baseline, 6 weeks, and months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
- Cognitive function [ Time Frame: Measured at baseline, and months 6 and 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
|
Placebo Comparator: 2
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 and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo 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. Study subjects will be followed for an additional six months for these endpoints.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
For growth hormone measurement part (for men and women):
- For visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and BMI greater than or equal to 25 kg/m2
- For lean controls: BMI 18.5 to 24.9 kg/m2
For growth hormone treatment part (for men and women):
- Visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, BMI greater than or equal to 25 kg/m2)
- IGF-I within the lowest 2 quartiles for age and gender
- 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 (in women)
- Pregnant or breastfeeding (in women)
- Polycystic ovary syndrome (in women)
- 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
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Karen K. Miller, MD | 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: | Karen Klahr Miller, MD, Associate Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00131378 History of Changes |
| Other Study ID Numbers: | 525, MGH GCRC 678, 2004-P-000013, RO1 HL077674 |
| Study First Received: | August 16, 2005 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
Visceral obesity Growth hormone Cardiovascular risk Insulin resistance |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013