Abdominal Obesity
Conditions
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.
Interventions
DRUGPlacebo
placebo given by injection 2mg subcutaneously daily
DRUGTesamorelin
The Growth Hormone Releasing Hormone analogue tesamorelin, 2mg subcutaneously daily by injection
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion/
Exclusion criteria
Inclusion Criteria for Lean Controls: 1. Men and women age 18-55y 2. BMI \> 18.5 and \< 25 kg/m2 3. Waist circumference \< 102 cm in men and \<88cm in women Inclusion criteria for Abdominal Obesity: 1. Men and women age 18-55y 2. BMI ≥ 30kg/m2 3. Abdominal obesity as defined by waist circumference ≥ 102 cm in men and ≥ 88 cm in women 4. Relative GH deficiency as demonstrated by peak GH to arginine/GHRH stimulation test of \< 9mcg/L (for treatment portion only) 5. Negative age-appropriate screening for cancer performed by primary care physician (e.g., negative mammogram if F \> 50yo) (For treatment portion only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aortic target to background ratio (Aortic TBR) | 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. |
Countries
United States
Outcome results
None listed