Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men - NCT00850564-02114 (Clinical Trial 274472)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy274472.aspx
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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Healthy Volunteers |
| Purpose: |
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The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing
Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will
increase GH pulse height and will not affect insulin sensitivity.
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| Study summary: |
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The primary objective of this study is to determine the effects of growth hormone releasing
hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as
well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg
Tesamorelin, subcutaneously, daily for two 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 Tesamorelin and will return
for an identical assessment after a 2 week withdrawal period. |
| Criteria: |
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Inclusion Criteria:
- Men aged 18-60 years
- BMI > 20kg/m2 and <35kg/m2
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 stimulating peptides within six months of starting the
study
- Change in lipid lowering or antihypertensive regimen within 3 months of screening
- Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine >
1.4 mg/dL
- 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 > 5
ng/mL
- Prior history of hypopituitarism, head irradiation or any other condition known to
affect the GH axis
- Weight < 110 lbs. |
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| Study is available at: |
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MGH
Boston, MA 02114
United States
Primary Contact:
Takara L Stanley, M.D.
Email: tstanley@parnters.org
Phone: 617-726-5312 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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