Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

Conditions
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Obesity

Intervention / Treatment
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* Drug: Nutropin AQ growth hormone
* Drug: Placebo Growth Hormone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male on GH<br>Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. | Drug: Nutropin AQ growth hormone<br>* Participants will give themselves injections of growth hormone every night for 6 months.<br>|
| Placebo Comparator: Male on Placebo<br>Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | Drug: Placebo Growth Hormone<br>* Participants will give themselves injections of placebo growth hormone every night for 6 months.<br>|
| Experimental: Female on GH<br>Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. | Drug: Nutropin AQ growth hormone<br>* Participants will give themselves injections of growth hormone every night for 6 months.<br>|
| Placebo Comparator: Female on Placebo<br>Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | Drug: Placebo Growth Hormone<br>* Participants will give themselves injections of placebo growth hormone every night for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HsCRP | 6 month change in HsCRP (primary cardiovascular risk endpoint) | Measured at baseline and month 6 | 
| Total Abdominal Fat | 6 month change in total abdominal fat (primary body composition endpoint) | Measured at baseline and month 6 | 
| Abdominal Fat | 6 month change in visceral abdominal fat (primary body composition endpoint) | Measured at baseline and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Insulin Resistance | 6 month change in 2-hour glucose (primary insulin resistance endpoint) | Measured at baseline and month 6 | 
| Insulin-like Growth Factor-1 (IGF-1) Levels | 6-month change in IGF-1 levels | Measured at baseline and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral obesity, Growth hormone, Cardiovascular risk, Insulin resistance