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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00131378 |
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women. 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 |
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Obesity |
Drug: Nutropin AQ growth hormone Drug: Placebo Growth Hormone |
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 |
Estimated Enrollment: | 110 |
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 |
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1: Experimental
Participants will receive growth hormone replacement therapy.
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Drug: Nutropin AQ growth hormone
Participants will give themselves injections of growth hormone every night for 6 months.
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2: Placebo Comparator
Participants will receive placebo.
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Drug: Placebo Growth Hormone
Participants will give themselves injections of placebo growth hormone every night for 6 months.
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The purpose of this study is to measure growth hormone levels in women of 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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For growth hormone measurement part (for women):
For growth hormone treatment part (for men and women):
Exclusion Criteria:
Contact: Danielle Brick | 617-724-0785 | Dbrick@partners.org |
Contact: Anu V. Gerweck, NP | 617-724-1837 | avg2@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Danielle Brick 617-724-0785 Dbrick@partners.org | |
Contact: Anu V. Gerweck, NP 617-724-1837 |
Principal Investigator: | Karen K. Miller, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Karen K. Miller, MD ) |
Study ID Numbers: | 525, MGH GCRC 678, 2004-P-000013, RO1 HL077674 |
Study First Received: | August 16, 2005 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00131378 History of Changes |
Health Authority: | United States: Federal Government |
Visceral obesity Growth hormone Cardiovascular risk Insulin resistance |
Body Weight Signs and Symptoms Obesity Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Nutrition Disorders |
Overweight Overnutrition Insulin Resistance Hormones Insulin |
Body Weight Signs and Symptoms Obesity Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Nutrition Disorders Overweight Overnutrition Hormones Pharmacologic Actions |