Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
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ClinicalTrials.gov Identifier: NCT00887393 |
Recruitment Status
:
Completed
First Posted
: April 24, 2009
Last Update Posted
: June 18, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Morbid Obesity Non-alcoholic Fatty Liver Disease | Other: low carbohydrate diet Other: low-fat diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Low carbohydrate
Low carbohydrate pre-bariatric surgery diet
|
Other: low carbohydrate diet
1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake)
|
Low fat
Low fat pre-bariatric surgery diet
|
Other: low-fat diet
1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake)
|
- Determine the efficacy of a low carbohydrate vs. a conventional low fat diet to reduce hepatic steatosis [ Time Frame: 8-9 weeks ]
- Compare differences in weight loss with a 2 month hypocaloric conventional low fat vs. low carbohydrate diets in individuals who are candidates for laparoscopic Roux-en-Y gastric bypass surgery or adjustable laparoscopic banding surgery [ Time Frame: 8-9 weeks ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants will be deemed as appropriate candidates by the University of Michigan Bariatric Surgery multidisciplinary committee to undergo laparoscopic Roux-Y gastric bypass surgery or adjustable laparoscopic banding surgery
- Age 18 to 65 years
- Willing and able to give informed consent
- Clinical diagnosis of non-alcoholic fatty liver disease based on presence of abnormal LFTS and/or abnormal liver ultrasound
- Able to have an MRI procedure (able to fit into scanner, largest width < 60 cm, weight < 400 lbs, largest girth < 74 inches, do not have a pacemaker, artificial limbs or any other medical devices that contain iron that may be affected by the MRI procedure).
- Willing and able to tolerate the MRI procedure (use of benzodiazepines to complete the procedure is allowed if needed and deemed safe by the study team)
Exclusion Criteria:
- Clinical history of diabetes or fasting glucose > 126 mg/dl
- Alcohol consumption of > 40 grams/week
- Any other liver disease
- BMI < 40 kg/m2
- Unable to ambulate
- Any other factor that in the opinion of the PI or co-investigators which may impede successful completion of the study

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): NCT00887393
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Elif A Oral, M.D. | University of Michigan |
Responsible Party: | Elif Oral, Assoc. Prof. Medicine, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00887393 History of Changes |
Other Study ID Numbers: |
MCRU 2462 |
First Posted: | April 24, 2009 Key Record Dates |
Last Update Posted: | June 18, 2013 |
Last Verified: | June 2013 |
Keywords provided by Elif Oral, University of Michigan:
morbid obesity non-alcoholic fatty liver disease bariatric surgery low fat diet low carbohydrate diet |
Additional relevant MeSH terms:
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Obesity, Morbid Digestive System Diseases Obesity |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |