Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity

August 22, 2011 updated by: Steven K. Grinspoon, MD, Massachusetts General Hospital

Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity

Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.

Study Overview

Status

Completed

Conditions

Detailed Description

Obesity is associated with significant morbidity and mortality and is a primary public health concern. Both the incidence and prevalence of obesity have increased over the last several decades, with obesity now affecting an estimated 31% of the American population. Recent data suggest that people with abdominal obesity commonly exhibit low levels of GH, which affects the body's growth rate and the way the body uses food for energy. Low GH levels and excess abdominal fat have been linked to improper functioning of the cardiovascular system and, therefore, may increase one's risk of cardiovascular disease. This study will determine the prevalence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.

Participation in this observational study will last between 2 and 4 weeks. The study will consist of two outpatient visits, held at either the Massachusetts General Hospital or Massachusetts Institute of Technology. Visit 1 will last 4 hours and will include a physical exam, medical history, blood draw, urine sampling, indirect calorimetry test, and growth hormone releasing hormone (GHRH)+Arginine stimulation test. Eligible participants will return within the next 3 weeks for Visit 2, which will last 5 hours. Before the second visit, participants will be asked to record their food intake for 4 days on a food record. During the visit, participants will have a repeat physical exam, urine sampling, and blood draw. Participants will also undergo an oral glucose tolerance test, whole body DEXA scan, abdominal computed tomography (CT) scan, and a carotid ultrasound. Participation in the study will end after Visit 2.

Study Type

Observational

Enrollment (Actual)

149

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants from the community at large who are able to come to either the Massachusetts General Hospital (MGH) Weight Center or Massachusetts Institute of Technology for study visits.

Description

Inclusion Criteria for Obesity:

  • Body mass index (BMI) greater than or equal to 30 kg/m2
  • Abdominal obesity, defined as waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women

Inclusion Criteria for Lean Controls:

  • BMI less than 25 kg/m2
  • Waist circumference less than 102 cm in men and less than 88 cm in women

Exclusion Criteria for both groups:

  • Obesity due to known secondary causes
  • Taking any weight lowering drugs
  • Previous bariatric surgery
  • Use of the following compounds within the 3 months prior to study entry: estrogen, progesterone, GH, GHRH, glucocorticoids, megesterol acetate, antidiabetic agents, oral contraceptive pills, or any other hormone or drug known to affect GH levels
  • Change in lipid lowering or antihypertensive regimen within 3 months prior to study entry
  • Use of testosterone or hormone replacement therapy
  • Previously known diabetes mellitus or other severe chronic illness
  • Hemoglobin less than 11.0 g/dL, creatinine greater than 1.5 mg/dL, or serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times the upper limit of normal
  • Follicle stimulating hormone (FSH) greater than 20 IU/L in women
  • Positive urine pregnancy test
  • Prior history of pituitary disease, pituitary surgery, head irradiation, or any other condition known to affect the GH axis

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

Cohorts and Interventions

Group / Cohort
1
Participants with abdominal obesity without growth hormone deficiency
2
Participants with abdominal obesity with growth hormone deficiency
3
Participants who are lean controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of growth hormone deficiency
Time Frame: Measured at baseline
Measured at baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines
Time Frame: Measured at baseline
Measured at baseline

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Steven K. Grinspoon, MD, Program in Nutritional Metabolism, 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, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 555
  • 1R01HL085268-01A1 (U.S. NIH Grant/Contract)

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.

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