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Clinical Trials/NCT01632592
NCT01632592
Withdrawn
Not Applicable

Abdominal Obesity, Cardiovascular Inflammation, and Effects of a Growth Hormone Releasing Hormone Analogue to Reduce Inflammation

Massachusetts General Hospital1 site in 1 countryJanuary 2014

Overview

Phase
Not Applicable
Intervention
Tesamorelin
Conditions
Abdominal Obesity
Sponsor
Massachusetts General Hospital
Locations
1
Primary Endpoint
aortic "target to background ratio" (Aortic TBR)
Status
Withdrawn
Last Updated
12 years ago

Overview

Brief Summary

Obesity is strongly associated with risk of cardiovascular disease (CVD). Data increasingly suggest that visceral adipose tissue (VAT) accumulation -- or increased abdominal fat -- is particularly deleterious to cardiovascular health, but further study is needed to test this idea. Increased abdominal fat may also be associated with lower secretion of a hormone called growth hormone (GH), which helps the body burn fat. The current study aims to carefully characterize relationships between abdominal fat and CVD. In addition, by using a medication called growth hormone releasing hormone, which is a strategy to reduce abdominal fat, the investigators will test the hypothesis that abdominal fat contributes uniquely to increased arterial inflammation.

In the first part of this study, the investigators will investigate both lean (healthy weight) individuals and individuals with increased abdominal fat. The investigators will study their body composition, cardiovascular risk measures, insulin sensitivity, and growth hormone dynamics, with the hypothesis that abdominal fat, independent of general obesity, will be strongly associated with arterial wall thickening and atherosclerotic inflammation. The investigators will assess arterial wall thickness, plaque morphology, and atherosclerotic inflammation, and the investigators will determine associations between these variables and regional fat accumulation, with particular attention to abdominal fat.

The second, treatment part of the study will be only for individuals with increased abdominal fat who are found to have low growth hormone secretion. In that part of the study, the investigators will test the effects of a growth hormone releasing hormone (GHRH) analogue to reduce abdominal fat and, consequently, reduce arterial inflammation. The investigators hypothesize that abdominal fat reduction, independent of changes in growth hormone, will reduce arterial inflammation and arterial wall thickness.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven K. Grinspoon, MD

Professor of Medicine, Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Inclusion Criteria for Lean Controls:
  • Men and women age 18-55y
  • BMI \> 18.5 and \< 25 kg/m2
  • Waist circumference \< 102 cm in men and \<88cm in women
  • Inclusion criteria for Abdominal Obesity:
  • Men and women age 18-55y
  • BMI ≥ 30kg/m2
  • Abdominal obesity as defined by waist circumference ≥ 102 cm in men and ≥ 88 cm in women
  • Relative GH deficiency as demonstrated by peak GH to arginine/GHRH stimulation test of \< 9mcg/L (for treatment portion only)
  • Negative age-appropriate screening for cancer performed by primary care physician (e.g., negative mammogram if F \> 50yo) (For treatment portion only)

Arms & Interventions

Growth Hormone Releasing Hormone

Growth Hormone Releasing Hormone analogue, 2mg subcutaneously every day for 12 months.

Intervention: Tesamorelin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

aortic "target to background ratio" (Aortic TBR)

Time Frame: 12 months

aortic target-to-background ratio is a measure of the inflammation in the wall of the aorta that is made by positron emission tomography (PET) scanning in conjunction with computed tomography (CT) scanning.

Study Sites (1)

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