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Completed

NCT Number: NCT00131378

Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutropin AQ growth hormone

Drug

Participants will give themselves injections of growth hormone every night for 6 months.

Placebo Growth Hormone

Drug

Participants will give themselves injections of placebo growth hormone every night for 6 months.

Primary outcomes

  1. HsCRP

    Time frame: Measured at baseline and month 6

    6 month change in HsCRP (primary cardiovascular risk endpoint)

  2. Total Abdominal Fat

    Time frame: Measured at baseline and month 6

    6 month change in total abdominal fat (primary body composition endpoint)

  3. Abdominal Fat

    Time frame: Measured at baseline and month 6

    6 month change in visceral abdominal fat (primary body composition endpoint)

Secondary outcomes

  1. Measure of Insulin Resistance

    Time frame: Measured at baseline and month 6

    6 month change in 2-hour glucose (primary insulin resistance endpoint)

  2. Insulin-like Growth Factor-1 (IGF-1) Levels

    Time frame: Measured at baseline and month 6

    6-month change in IGF-1 levels

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2013
First posted
Aug 18, 2005
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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