Conditions: Obesity
Keywords: Visceral obesity Growth hormone Cardiovascular risk Insulin resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: yes

Brief summary:
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:
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.

Arms:
arm 1: 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. arm 2: Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. arm 3: 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. arm 4: Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.

Interventions: intervention 1: Nutropin AQ growth hormone intervention 2: Placebo Growth Hormone
Intervention descriptions: intervention 1: Participants will give themselves injections of growth hormone every night for 6 months. intervention 2: Participants will give themselves injections of placebo growth hormone every night for 6 months.

Protocol document: