De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease

Completed · Not applicable

Conditions studied: Non-alcoholic Fatty Liver Disease, Diabetes

In brief

The worldwide epidemic of obesity is paralleled with increased cases of non-alcoholic liver disease (liver fat accumulation) and diabetes. Fat belongs in the adipose tissue, and if excess fat accumulates in the liver or muscle, these tissues cannot use sugar efficiently. It has been discovered that when large quantities of fructose (a sugar present in soft drinks) are consumed, the conversion of carbohydrate (CHO) to fat in the liver increases. We hypothesize that: 1) subjects with fatty liver have a higher CHO uptake and conversion to fat in their liver when compared to matched control subjects with normal liver fat content; and that: 2) when subjects with fatty liver are fed a diet limiting fructose and simple sugars will decrease their liver CHO fat content. This reduction in liver fat will normalize the way the liver responds to sugar and insulin, reversing the pre-diabetic state. The measurement of these parameters will be done using state-of-the-art techniques such as safe non-radioactive isotope tracers and non-invasive magnetic resonance spectroscopy. For more information, please call 415-206-5532 for a phone screening

Key facts

Study ID

NCT00714129

Run by

University of California, San Francisco

People needed

41

Starts

2007-09-01

Expected to finish

2012-10-12

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In the steatotic subjects, steatosis will be diagnosed by MRS or liver biopsy in which >33% of the hepatocytes will contain fat. Non-steatotic controls will not have biopsies since they are not medically warranted; thus, to ensure they do not have steatosis they will undergo MRS during screening and have a total lipid: unsuppressed water < 0.05.

You may not qualify if…

• Habitual consumption of alcohol > 20 g/day for men and 10 g/day for women
• Confirmed HIV-1 infection, Hgb <13 g/dL for males and <12 g/dL for females
• Abnormal hepatitis B or C serology
• Diabetes or current use of any antidiabetic or hypolipidemic agents
• Presence of metal-containing substances in the body (e.g. a fragment in the eye, aneurysm clips, ear implants, spinal nerve stimulators or a pacemaker)
• Weight over 350 pounds or severe claustrophobia, which would preclude the MR studies
• Any condition that would preclude adherence to the protocol or the ability to provide informed consent
• Change in body weight >5% within the preceding 6 months (by self-report)
• Known intolerance, allergy or hypersensitivity to fructose
• Pregnancy or lactation (for women); OR
• Any other condition that, in the opinion of the investigators, would put the subject at risk.

Where it is running

• Touro University — Vallejo, California, United States

Full record on ClinicalTrials.gov

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