De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease (LINC)
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ClinicalTrials.gov Identifier: NCT00714129 |
Recruitment Status
:
Active, not recruiting
First Posted
: July 14, 2008
Last Update Posted
: October 26, 2017
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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.
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-alcoholic Fatty Liver Disease Diabetes | Other: Dietary intervention (calorie restricted diet) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease |
Study Start Date : | September 2007 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Weight loss diet - normal diet
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Other: Dietary intervention (calorie restricted diet)
Participants in Aim 2 will receive a calorie restricted diet. This group will receive all their food for approximately 8 weeks which is the similar composition of their current diet.
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Experimental: 2
Weight loss diet - low in simple sugars (specifically fructose)
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Other: Dietary intervention (calorie restricted diet)
Participants in Aim 2 will receive a calorie restricted diet. This group will receive all their food for approximately 8 weeks which is lower in simple sugars, specifically fructose.
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- Stable isotopic and magnetic resonance measures to determine the changes in lipid and carbohydrate metabolism after dietary intervention [ Time Frame: approximately 8 weeks ]
- DEXA, insulin sensitivity and energy expenditure changes due to dietary intervention [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714129
United States, California | |
Touro University | |
Vallejo, California, United States, 94592 |
Principal Investigator: | Jean-Marc Schwarz, PhD | Touro University and UCSF |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00714129 History of Changes |
Other Study ID Numbers: |
R01DK078133-01 ( U.S. NIH Grant/Contract ) NIH R01DK078133-01A1 ADA 1-08-CR-56 |
First Posted: | July 14, 2008 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Keywords provided by University of California, San Francisco:
Steatosis Diabetes |
Additional relevant MeSH terms:
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |