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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01511016 |
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Date of registration:
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11/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
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Scientific title:
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The Effect of Leptin Therapy on Abnormal Lipid Kinetics in Subjects With HIV Lipodystrophy Syndrome |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01511016 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Ashok Balasubramanyam, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- predominantly lipoatrophic or mixed phenotype of HIV-lipodystrophy (based on
self-observation and evaluation by a study physician utilizing a visual scale;
- AM fasting leptin < 4.0 ng/ml
- hypertriglyceridemia (fasting serum TG 250-1000 mg /dl).
- normal biochemistry (except altered lipid and glucose profile). Patients with the
American Diabetes Association diagnostic criteria for diabetes were included provided
the HbA1c level was <7.5% and they received no anti-diabetic medications for at least
3 months.
- well-controlled HIV infection status evidenced by viral RNA titers <400 copies/ml, on
stable HAART.
Exclusion Criteria:
- acute or chronic illnesses.
- use of antidiabetic medications in the previous 3 months, or of lipid-lowering drugs
in the previous 6 weeks are also exclusion criteria. Other drugs excluded are growth
hormone (if used without evidence of growth hormone deficiency), Megace and
testosterone (if used without evidence of hypogonadism).
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV Lipodystrophy
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Intervention(s)
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Drug: Placebo
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Drug: Human recombinant leptin ("metreleptin")
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Primary Outcome(s)
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Rate of Net Lipolysis
[Time Frame: 4 months after treatment]
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Rate of Total Lipolysis
[Time Frame: 4 months after treatment]
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Secondary Outcome(s)
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Insulin Levels After Oral Glucose Challenge.
[Time Frame: 4 months after treatment.]
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Rates of Fatty Acid Oxidation
[Time Frame: 4 months after treatment]
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Glucose Levels After Glucose Challenge
[Time Frame: 4 months after treatment.]
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Fasting Plasma Non-HDL-C
[Time Frame: 4 months after treatment.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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