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

NCTNCT01632592Other id2012p-000917

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: No funding available

Overview

Status: Withdrawn
Phase: Not applicable
Enrollment: 0 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Jan 2014
Primary completion: Jan 2014
Completion: Jan 2014
First posted: 3 Jul 2012 (estimated)
Last update posted: 24 Jan 2014 (estimated)
Conditions: Abdominal Obesity

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142015

N/A
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
NCT01632592
Jan 2014 to Jan 2014
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

TesamorelinDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

aortic "target to background ratio" (Aortic TBR)
Time frame · 12 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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) Exclusion criteria for all subjects: 1. Obesity due to known secondary causes 2. Use of weight-lowering drugs or previous weight loss surgery 3. Use of gonadal steroids, GH, GHRH, glucocorticoids, megesterol acetate, antidiabetic agents, or any other hormonal medication judged by the investigator to be inappropriate within the past 6 months. Use of physiologic testosterone replacement will be allowed. 4. Statin use 5. Known coronary artery disease or peripheral vascular disease, or any history of stroke or significant chest pain 6. Known auto-immune or inflammatory disease 7. Any surgery or significant injury (including fracture or other trauma) within the past 6 months 8. Hemoglobin \< 11g/dL, fasting glucose \> 126mg/dL, creatinine \<1.5mg/dL, or AST \> 2.5x upper limit of normal 9. FSH \> 20 IU/L (women only) 10. Positive urine pregnancy test, actively seeking pregnancy, or breastfeeding 11. Prior history of pituitary disease, pituitary surgery, or head irradiation, or any other condition known to affect pituitary function 12. Infectious illness in the past 3 months, or chronic infectious illness 13. Allergy to iodine containing contrast media 14. Active illicit drug use 15. For women of childbearing potential, failure to use an acceptable form of non-hormonal birth control 16. Active malignancy: For the treatment part of the study, all active malignancy will be excluded. For the observational part of the study (which involves no intervention) basal cell carcinoma and low grade cervical or anal intraepithelial neoplasms will be allowed. 17. History of colon cancer (treatment part only)

PepBank is a research reference. Talk to a doctor before you use any peptide.