Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

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Brief Title

Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

Official Title

Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity

Brief Summary

      Obesity, a condition that occurs when a person has too much body fat, affects about 31% of
      people in the United States. It is associated with increased risk of diabetes, high blood
      pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is
      also associated with low levels of growth hormone, a hormone that affects rate of growth and
      the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that
      makes the body naturally increase its own growth hormone levels. Administering GHRH to people
      who are obese may help return their growth hormone levels to normal and, in turn, may lead to
      reduced abdominal fat and improved cardiovascular function. This study will evaluate the
      effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving
      cardiovascular function in people who are obese.
    

Detailed Description

      Obesity, defined as having a high amount of excess body fat, is one of the most wide-spread
      health problems of today. A variety of factors can lead to obesity. These factors include
      physical inactivity, family history and genetics, metabolism, and hormone imbalance. The
      excess body fat in obesity increases a person's risk of a number of life-threatening
      diseases, including heart disease, gall stones, type 2 diabetes, and certain types of cancer.
      People with abdominal obesity, where fat is stored predominantly around a person's
      midsection, are particularly prone to weight-related diseases. Studies have shown that
      administration of growth hormone to obese people reduces abdominal fat, but can be associated
      with adverse side effects. GHRH is a natural hypothalamic peptide that stimulates growth
      hormone release. GHRH may be able to normalize growth hormone levels, reduce abdominal fat,
      and lessen risk for cardiovascular disease in people who are obese, without the associated
      side effects of growth hormone administration. However, further study is needed on GHRH. This
      study will evaluate the safety and effectiveness of synthetic GHRH in decreasing the amount
      of abdominal fat and improving cardiovascular function in people who are obese.

      Participation is this study will last 1 year from screening and will include 9 study visits.
      During Visit 1, participants will undergo screening tests that will include a medical
      history, a physical exam, body measurements, a blood draw, a urine test, a GHRH+Arginine
      stimulation test, an electrocardiogram (ECG), and a test for the presence of blood in stool.
      Eligible participants will return within the next 3 weeks for an inpatient clinic stay for
      Visit 2. Participants will be asked to keep a food record of all food consumed during the 4
      days before the second visit. Visit 2 will include a physical exam, a medical and smoking
      history, a review of current medications, body measurements, an overnight blood draw, a body
      metabolism evaluation, an oral glucose tolerance test, and two questionnaires. Also during
      Visit 2, participants will be assigned randomly to treatment with active GHRH or placebo.
      Participants will then be taught how to give themselves injections of the study drug, which
      will be taken daily for 12 months. Participants will also receive a 1-month supply of study
      drug and will be supplied with refills in subsequent study visits. Upon starting treatment,
      participants will undergo more testing, including a whole body DEXA scan, abdominal computed
      tomography (CT) scan, carotid ultrasound, and ECG.

      Visit 3 will occur at Week 2 of treatment and will include a review of study medications,
      questions about any side effects experienced, vital sign measurements, a blood draw, an ECG,
      and, if female, a urine test. Visits 4, 5, and 7 will be identical to Visit 3 and will occur
      at Months 1, 3, and 9 respectively. Visit 6 will occur at Month 6 and will be identical to
      Visit 2 but without the overnight blood draw. Visit 8 will occur at Month 12 and will be
      identical to Visit 2, except no further study drug will be dispensed. At Month 13,
      participants will complete the final study visit, which will include repeat tests from Visit
      1.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Visceral Adipose Tissue Volume

Secondary Outcome

 Change in Carotid Intima-media Thickness

Condition

Abdominal Obesity

Intervention

Growth hormone releasing hormone (GHRH) 1-44

Study Arms / Comparison Groups

 1
Description:  Participants will receive treatment with growth hormone releasing hormone 1-44 (TH9507).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

July 2008

Completion Date

January 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Body mass index (BMI) greater than or equal to 30 kg/m2

          -  Waist circumference greater than or equal to 102 cm in men and greater than or equal
             to 88 cm in women

          -  Relative growth hormone (GH) deficiency, defined as a peak GH value of less than or
             equal to 8 ng/mL on Arginine-GHRH stimulation test

          -  Hemoglobin level greater than 12.0 g/dL

          -  Serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase less
             than 2.5 times the upper limit of normal

          -  Creatinine level less than 1.5 mg/dL

          -  Follicle stimulating hormone less than 20 IU/L in women

          -  Negative mammogram within 1 year of study entry for women older than 40 years of age

        Exclusion Criteria:

          -  Obesity due to a known secondary cause (e.g., Cushing's syndrome, hypothyroidism) or a
             history of gastric bypass procedure

          -  Known hypersensitivity to GHRH 1-44 (TH9507)

          -  Known history of diabetes, fasting blood sugar less than 125 mg/dL, or antidiabetic
             drug use

          -  Using any weight lowering drugs

          -  Using estrogen, hormone replacement therapy, oral contraceptives, testosterone,
             glucocorticoids, anabolic steroids, GHRH, GH, or insulin-like growth factor-1 (IGF-1)
             within 3 months of study entry

          -  Changes in lipid lowering or antihypertensive regimen within 3 months of study entry

          -  Long-term illness, including anemia, chronic kidney disease, and liver disease

          -  History of cancer (except patients with surgically cured basal cell or squamous cell
             skin cancers) or history of abnormalities on age appropriate malignancy screen,
             including mammography, colonoscopy, and prostate exam (or prostate specific antigen
             greater than 5 ng/mL)

          -  History of hypopituitarism, pituitary surgery, pituitary/brain radiation, traumatic
             brain injury, or any other condition known to affect the growth hormone axis

          -  History of any recent cardiovascular event, including heart attack, stroke, transient
             ischemic attack, unstable angina pectoris, or oxygen-dependent severe pulmonary
             disease, within 3 months of study entry

          -  Clinical depression or other psychiatric illness that will not allow completion of the
             study as per investigator's judgement

          -  History of or current eating disorder

          -  History of recent alcohol or substance abuse (less than 1 year before study entry)

          -  Positive pregnancy test or breastfeeding females and positive fecal occult blood test

          -  Women of childbearing potential not currently using nonhormonal birth control methods,
             including barrier methods (e.g., IUD, condoms, diaphragms) or abstinence

          -  Currently enrolled in another investigational device or drug trial(s) or has received
             other investigational agent(s) within 28 days of study entry

          -  Any condition that would make this clinical trial detrimental to the patient, as
             judged by the patient's physician

          -  History of noncompliance with other therapies

          -  Any condition in which compliance with the study protocol is unlikely
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Steven K. Grinspoon, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00675506

Organization ID

574

Secondary IDs

1R01HL085268-01A1

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

November 2017