Back to results

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

Primary Purpose

Abdominal Obesity

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tesamorelin

Placebo

About this trial

This is an interventional treatment trial for Abdominal Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion/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)

Exclusion criteria for all subjects:

Obesity due to known secondary causes
Use of weight-lowering drugs or previous weight loss surgery
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.
Statin use
Known coronary artery disease or peripheral vascular disease, or any history of stroke or significant chest pain
Known auto-immune or inflammatory disease
Any surgery or significant injury (including fracture or other trauma) within the past 6 months
Hemoglobin < 11g/dL, fasting glucose > 126mg/dL, creatinine <1.5mg/dL, or AST > 2.5x upper limit of normal
FSH > 20 IU/L (women only)
Positive urine pregnancy test, actively seeking pregnancy, or breastfeeding
Prior history of pituitary disease, pituitary surgery, or head irradiation, or any other condition known to affect pituitary function
Infectious illness in the past 3 months, or chronic infectious illness
Allergy to iodine containing contrast media
Active illicit drug use
For women of childbearing potential, failure to use an acceptable form of non-hormonal birth control
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.
History of colon cancer (treatment part only)

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Growth Hormone Releasing Hormone

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

aortic "target to background ratio" (Aortic TBR)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01632592

First Posted

June 27, 2012

Last Updated

January 23, 2014

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01632592

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Withdrawn

Why Stopped

No funding available

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Growth Hormone Releasing Hormone

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tesamorelin

Intervention Description

The Growth Hormone Releasing Hormone analogue tesamorelin, 2mg subcutaneously daily by injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo given by injection 2mg subcutaneously daily

Primary Outcome Measure Information:

Title

aortic "target to background ratio" (Aortic TBR)

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion/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) Exclusion criteria for all subjects: Obesity due to known secondary causes Use of weight-lowering drugs or previous weight loss surgery 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. Statin use Known coronary artery disease or peripheral vascular disease, or any history of stroke or significant chest pain Known auto-immune or inflammatory disease Any surgery or significant injury (including fracture or other trauma) within the past 6 months Hemoglobin < 11g/dL, fasting glucose > 126mg/dL, creatinine <1.5mg/dL, or AST > 2.5x upper limit of normal FSH > 20 IU/L (women only) Positive urine pregnancy test, actively seeking pregnancy, or breastfeeding Prior history of pituitary disease, pituitary surgery, or head irradiation, or any other condition known to affect pituitary function Infectious illness in the past 3 months, or chronic infectious illness Allergy to iodine containing contrast media Active illicit drug use For women of childbearing potential, failure to use an acceptable form of non-hormonal birth control 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. History of colon cancer (treatment part only)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Grinspoon, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs