N/A N=142 Randomized Double-blind Treatment

Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00131378 ↗

Enrolled (actual)

142

Serious AEs

1.4%

Results posted

Mar 2014

Primary outcome: Primary: HsCRP — -1.1; 0.5; -1.3; -0.3 mg/L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nutropin AQ growth hormone (Drug); Placebo Growth Hormone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY HsCRP	-1.1; 0.5; -1.3; -0.3	—
PRIMARY Total Abdominal Fat	-28.0; 1.5	—
PRIMARY Abdominal Fat	-15.9; -0.2	—
SECONDARY Measure of Insulin Resistance	5.3; -12.5; 18.6; -0.9	—
SECONDARY Insulin-like Growth Factor-1 (IGF-1) Levels	179.0; 9.9; 106.5; -20.8	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00131378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.