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NCT01262326 · ClinicalTrials.gov registry record · NA
Determination of the Effect of Extreme Dietary Carbohydrate Restriction on Hepatic Glucose Production
A NA study of Non-alcoholic Fatty Liver Disease, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01262326 is a NA study of Non-alcoholic Fatty Liver Disease that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, below the 189-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01262326, a NA study of Non-alcoholic Fatty Liver Disease, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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, waist/hip circumference and vital signs. Additionally, blood will be drawn at this visit to screen for renal dysfunction (Chem 10), liver disease (liver function tests (LFT's)), thyroid dysfunction (TSH), diabetes mellitus (HbA1C), and chronic inflammatory states (erythrocyte sedimentation rate). Subjects recruited to the study will be placed on a low-carbohydrate diet (\<20 g/d without caloric restriction) designed either to promote weight loss or maintain weight stability for fourteen days prior to the protocol or they will consume a typical "Western" diet designed either to promote weight loss (restricted by 1300 kcal/d in the final fourteen days) or maintain weight stability for twenty-one days. Subjects recruited to the study will be lean, overweight, or obese and also may carry a diagnosis of NAFLD. Target accrual for total enrollment for this project will be set to 80 subjects to accommodate attrition and screen failures. The details of the low-carbohydrate diet have been discussed in consultation with Linda Brinkley, nutrition staff of the CTRC. Subjects chosen to undergo carbohydrate-restriction will have a teaching session with a CTRC dietician. Subjects will then initiate dietary carbohydrate-restriction on their own and keep a daily dietary record for seven days. At the end of seven days, the dietary record will be analyzed. The CTRC will then prepare all meals for the final seven days of the diet in accordance with daily caloric intake calculated from the dietary record. Calorie-restricted participants will keep a dietary record for one week while eating a typical "Western" diet. The dietician will analyze this record and meals restricted by 1300 kcal/d will be prepared by the CTRC for the final fourteen days of the diet. Alternatively, some subjects eati
Conditions Studied
Interventions
- OTHER Calorie and Carbohydrate Restriction
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01262326
The ClinicalTrials.gov registry entry for NCT01262326 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (68% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Calorie and Carbohydrate Restriction is the first listed.
NCT01262326 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01262326 about?
NCT01262326 is a clinical study titled "Determination of the Effect of Extreme Dietary Carbohydrate Restriction on Hepatic Glucose Production". 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, waist/hip circumference and vital signs. Additionally, blood will be drawn at this visit to screen...
What is the current status of trial NCT01262326?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2005-01. Estimated completion is 2011-12-31.
What conditions does trial NCT01262326 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT01262326?
The interventions under investigation include: Calorie and Carbohydrate Restriction (OTHER).
Who is sponsoring clinical trial NCT01262326?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01262326 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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