Status:
COMPLETED
Determination of the Effect of Extreme Dietary Carbohydrate Restriction on Hepatic Glucose Production
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
All subjects will be evaluated by the Research Nurse at the Clinical Translational Research Center (CTRC) Outpatient Clinic to obtain informed consent, a brief medical history, weight, body mass index...
Eligibility Criteria
Inclusion
- The study will compare sources of hepatic glucose in individuals age 18 to 65 years matched for age, body mass index (BMI), gender, and ethnicity. Enrollment numbers will be higher to accommodate attrition and matching. The genders will be equally represented in both cohorts. The ethnicity of the participants will be chosen to match the general population in the Dallas area. Spanish speaking subjects will be eligible for enrollment. No cultural or ethnic background will be systematically excluded. The present study will be restricted to subjects who are overweight (25\>BMI\<35). All subjects will have a normal nutritional status and minimal ethanol intake (\< 10 g/d). Because activity level is known to alter hepatic metabolism, the subjects chosen will be those who do not participate in regular exercise above the amount of activity associated with daily living. Participation in concurrent studies will be determined on a case-by-case basis. Informed consent will be obtained from all participants.
- The investigators will also enroll subjects diagnosed with NAFLD from Dr. Browning's clinical hepatology practice.
- Based upon the need to study the effects of macronutrient manipulation under a variety of conditions, the targeted enrollment for this protocol will be open-ended. This will allow the present application to act as the basis for studying hepatic metabolism under a variety of conditions. The enrollment target is 80 subjects.
Exclusion
- In order to eliminate confounding variables, the participants chosen will have to be in stable health, on no medications known to alter hepatic glucose metabolism, on no weight loss diet or diet pills within the previous 6 months, and without baseline ketonuria. The present study will be restricted to subjects who are overweight (25\>BMI\<35). Subjects with a history of renal calculi, gout/hyperuricemia, renal insufficiency, will also be excluded from the study. Pregnant women, children, and institutionalized individuals will also be excluded. NAFLD subjects with metal in or on their body will be excluded.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01262326
Start Date
January 1 2005
End Date
December 31 2011
Last Update
November 16 2018
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75022