Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

March 9, 2016 updated by: Karen Klahr Miller, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HsCRP
Time Frame: Measured at baseline and month 6
6 month change in HsCRP (primary cardiovascular risk endpoint)
Measured at baseline and month 6
Total Abdominal Fat
Time Frame: Measured at baseline and month 6
6 month change in total abdominal fat (primary body composition endpoint)
Measured at baseline and month 6
Abdominal Fat
Time Frame: Measured at baseline and month 6
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
Time Frame: Measured at baseline and month 6
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
Time Frame: Measured at baseline and month 6
6-month change in IGF-1 levels
Measured at baseline and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Karen K. Miller, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 16, 2005

First Posted (ESTIMATE)

August 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 525
  • MGH GCRC 678
  • 2004-P-000013
  • R01HL077674 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Nutropin AQ growth hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe