Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00887393 · ClinicalTrials.gov registry record · NA
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
A NA study of Non-alcoholic Fatty Liver Disease and Morbid Obesity, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00887393: Completed NA study of Non-alcoholic Fatty Liver Disease and Morbid Obesity, sponsored by University of Michigan.
NCT00887393 is a NA study of Non-alcoholic Fatty Liver Disease and Morbid Obesity that has completed, run by University of Michigan. The registered enrollment target is 31 participants, below the 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00887393, a NA study of Non-alcoholic Fatty Liver Disease and Morbid Obesity, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver. The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase the operative complications of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduce complications of surgery. Most bariatric surgery programs use a conventional low fat, calorie restricted diet during the preparation phase for surgery. The investigators will compare the effects of the low carbohydrate versus the low fat diets on weight loss, reduction in liver fat content, and liver size. These results will provide new clinical insights into the optimal dietary intervention to make bariatric surgery safe and effective for the increasing numbers of patients opting for this aggressive therapy for morbid obesity. Patients approved for bariatric surgery by the University of Michigan Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to 1200 calorie low fat or low carbohydrate, 8-week study diet. All the food for this study will be provided for free by the study team. Participants will be required to meet with the study team weekly to pick up study food and for a nutritional consult. These visits will occur in the eight weeks preceding the patient's bariatric surgery procedure. During the bariatric surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat content.
Conditions Studied
Interventions
- OTHER low carbohydrate diet
- OTHER low-fat diet
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT00887393 record still lists
NCT00887393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which low carbohydrate diet is the first listed.
NCT00887393 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT00887393 about?
NCT00887393 is a clinical study titled "Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates". Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver. The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase the operative complications of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduc...
What is the current status of trial NCT00887393?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2009-04. Estimated completion is 2012-12.
What conditions does trial NCT00887393 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Morbid Obesity.
What interventions are being tested in trial NCT00887393?
The interventions under investigation include: low carbohydrate diet (OTHER), low-fat diet (OTHER).
Who is sponsoring clinical trial NCT00887393?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00887393 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-alcoholic Fatty Liver Disease
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 NCT00887393's enrollment target sits among peer trials
31 46th of 57 higher than 12 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Intermittent Fasting for NAFLD in Adults
RECRUITING · NA
-
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
RECRUITING · NA
-
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
RECRUITING · NA
-
The Olmsted NAFLD Epidemiology Study (TONES)
RECRUITING · NA
-
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
RECRUITING · NA
-
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia