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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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16 December 2017 |
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Main ID: |
NCT00637520 |
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Date of registration:
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12/03/2008 |
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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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Insulin Resistance in Nonalcoholic Fatty Liver Disease: A Case Control Study
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Scientific title:
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Insulin Resistance in Nonalcoholic Fatty Liver Disease: A Case Control Study |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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29 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00637520 |
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Study type:
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Observational |
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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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Manal F Abdelmalek, MD., MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty Member |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biochemical and liver histologic features to confirm the presence of a healthy liver,
fatty liver, and/or non-fatty liver with inflammation due to another etiology besides
NAFLD.
Exclusion Criteria:
- > 20 grams of alcohol/day
- Impaired oral glucose tolerance test
- Clinical or histologic evidence of cirrhosis (stage 5-6 fibrosis) or portal
hypertension.
- Chronic hepatitis C infection
- Known diabetes mellitus or need for insulin-sensitizing agents and/or insulin therapy.
- Pregnancy
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Nonalcoholic Fatty Liver Disease
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Primary Outcome(s)
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Determine if IR is associated with altered parameters of lipid metabolism as compared to matched controls
[Time Frame: 36 months]
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Measure Insulin Resistance (IR) and clearance its effects on lipid metabolism, inflammatory response, and oxidative stress using intravenous glucose tolerance testing in patients with NAFLD as compared to matched controls.
[Time Frame: 36 months]
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Measure the differential effects of IR and lipid metabolism on peripheral mononuclear cell (PBMC) inflammatory response and the associated hepatocyte mitochondrial ultrastructure and measures of oxidative stress.
[Time Frame: 36 Months]
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Secondary ID(s)
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8592
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Pro00006742
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NIH K23 Award
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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