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NCT00968747 · ClinicalTrials.gov registry record · NA
Regulation of FGF21 by Nutritional Challenges
A NA study of Non-Alcoholic Fatty Liver Disease (NAFLD) and Fasting, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00968747: Completed NA study of Non-Alcoholic Fatty Liver Disease (NAFLD) and Fasting, sponsored by Beth Israel Deaconess Medical Center.
NCT00968747 is a NA study of Non-Alcoholic Fatty Liver Disease (NAFLD) and Fasting that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 40 participants, below the 87-participant average among 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00968747, a NA study of Non-Alcoholic Fatty Liver Disease (NAFLD) and Fasting, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue. This study will have several aims. One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss. THIS ARM IS CURRENTLY NOT RECRUITING Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome. THIS ARM IS CURRENTLY RECRUITING
Primary Outcome
Change in FGF21 levels following nutritional intervention.
Conditions Studied
Interventions
- BEHAVIORAL Diet
- BEHAVIORAL Fasting
- DIETARY_SUPPLEMENT oral carbohydrate challenge
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-07 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
What the finished NCT00968747 record still lists
NCT00968747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 87-participant average among 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Non-Alcoholic Fatty Liver Disease (NAFLD) appearing as the primary indexed condition, and to 3 interventions - of which Diet is the first listed.
NCT00968747 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00968747 about?
NCT00968747 is a clinical study titled "Regulation of FGF21 by Nutritional Challenges". The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue. This study will have several aims. One aim is to examine the effect of 72 hours of fasting on fibroblast growt...
What is the current status of trial NCT00968747?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-07. Estimated completion is 2023-07-31.
What conditions does trial NCT00968747 study?
This clinical trial studies the following conditions: Non-Alcoholic Fatty Liver Disease (NAFLD), Fasting.
What interventions are being tested in trial NCT00968747?
The interventions under investigation include: Diet (BEHAVIORAL), Fasting (BEHAVIORAL), oral carbohydrate challenge (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00968747?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00968747 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Alcoholic Fatty Liver Disease (NAFLD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00968747's enrollment target sits among peer trials
40 5th of 9 higher than 4 of 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Alcoholic Fatty Liver Disease (NAFLD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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