Effects of Short-term Growth Hormone in HIV-infected Patients

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Brief Title

Effects of Short-term Growth Hormone in HIV-infected Patients

Official Title

Effects of Short-term Growth Hormone in HIV-infected Patients

Brief Summary

      The purpose of this study is to examine the short-term effects of two different doses of
      growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's
      secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth
      hormone administration will alter the body's endogenous pulsatile growth hormone secretion
      and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that
      growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to
      insulin sensitivity.
    

Detailed Description

      The primary objective of this study is to determine the differential effects of growth
      hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose
      GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility,
      as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized
      to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic
      "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. At baseline and after two
      weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as
      insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will
      return for an identical assessment after a 2 week withdrawal period.
    


Study Type

Interventional


Primary Outcome

Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug

Secondary Outcome

 Insulin Sensitivity

Condition

HIV Lipodystrophy

Intervention

Growth hormone

Study Arms / Comparison Groups

 GH 6mcg/kg/d
Description:  Recombinant human growth hormone 6mcg/kg SC once daily

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

25

Start Date

February 2009

Completion Date

November 2012

Primary Completion Date

November 2012

Eligibility Criteria

        Inclusion Criteria:

          -  previously diagnosed HIV infection

          -  Stable antiretroviral regimen for at least 12 weeks prior to enrollment

          -  Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist
             circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of
             treatment for HIV disease

          -  Subjective evidence of at least one of the following changes, occurring during the
             treatment of HIV disease: increased abdominal girth, relative loss of fat in the
             extremities, or relative loss of fat in the face

        Exclusion Criteria:

          -  Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months
             of the study

          -  Use of GH or Growth hormone releasing factor within six months of starting the study

          -  Change in lipid lowering or antihypertensive regimen within 3 months of screening

          -  Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4
             mg/dL, FSH > 20 IU/L in women, or CD4 count < 200

          -  Carpal tunnel syndrome

          -  Severe chronic illness or active malignancy or history of pituitary malignancy or
             history of colon cancer

          -  For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5ng/mL

          -  Prior history of hypopituitarism, head irradiation, or any other condition known to
             affect the GH axis

          -  positive beta-HCG (women only)

          -  Oral contraceptives, depo provera, or combined progesterone-estrogen injections,
             transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months
             of the study

          -  weight < 110 pounds
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Steven K Grinspoon, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00795210

Organization ID

DK63639A

Secondary IDs

R01DK063639

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Steven K Grinspoon, M.D., Principal Investigator, Massachusetts General Hospital


Verification Date

October 2013