Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00131378
First received: August 16, 2005
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Drug: Nutropin AQ growth hormone
Drug: Placebo Growth Hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • HsCRP [ Time Frame: Measured at baseline and month 6 ] [ Designated as safety issue: No ]
    6 month change in HsCRP (primary cardiovascular risk endpoint)

  • Total Abdominal Fat [ Time Frame: Measured at baseline and month 6 ] [ Designated as safety issue: No ]
    6 month change in total abdominal fat (primary body composition endpoint)

  • Abdominal Fat [ Time Frame: Measured at baseline and month 6 ] [ Designated as safety issue: No ]
    6 month change in visceral abdominal fat (primary body composition endpoint)


Secondary Outcome Measures:
  • Measure of Insulin Resistance [ Time Frame: Measured at baseline and month 6 ] [ Designated as safety issue: Yes ]
    6 month change in 2-hour glucose (primary insulin resistance endpoint)

  • Insulin-like Growth Factor-1 (IGF-1) Levels [ Time Frame: Measured at baseline and month 6 ] [ Designated as safety issue: Yes ]
    6-month change in IGF-1 levels


Enrollment: 142
Study Start Date: November 2004
Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Male on GH

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
Participants will give themselves injections of growth hormone every night for 6 months.
Placebo Comparator: Male on Placebo

Participants received placebo.

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

Drug: Placebo Growth Hormone
Participants will give themselves injections of placebo growth hormone every night for 6 months.
Experimental: Female on GH

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
Participants will give themselves injections of growth hormone every night for 6 months.
Placebo Comparator: Female on Placebo

Participants received placebo.

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

Drug: Placebo Growth Hormone
Participants will give themselves injections of placebo growth hormone every night for 6 months.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For growth hormone measurement part (for men and women):

    1. 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
    2. For lean controls: BMI 18.5 to 24.9 kg/m2
  • For growth hormone treatment part (for men and women):

    1. 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)
    2. IGF-I within the lowest 2 quartiles for age and gender
    3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131378

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen K. Miller, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Klahr Miller, MD, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00131378     History of Changes
Other Study ID Numbers: 525, MGH GCRC 678, 2004-P-000013, RO1 HL077674
Study First Received: August 16, 2005
Results First Received: August 19, 2013
Last Updated: February 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Visceral obesity
Growth hormone
Cardiovascular risk
Insulin resistance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014