Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Condition: Abdominal Obesity; Growth Hormone Deficiency
MeSH terms: Obesity; Obesity, Abdominal
Intervention: Growth hormone releasing hormone (GHRH) 1-44; Placebo
Intervention description: 2-mg sub-cutaneous injections once daily for 12 months; 2-mg sub-cutaneous injections once daily for 12 months
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Growth Hormone Releasing Hormone; Growth Hormone Pulse; Visceral Adipose Tissue; Carotid Intima-Media Thickness

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.
    

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