Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elif Oral, University of Michigan
ClinicalTrials.gov Identifier:
NCT00887393
First received: April 22, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Morbid Obesity
Non-alcoholic Fatty Liver Disease
Other: low carbohydrate diet
Other: low-fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Determine the efficacy of a low carbohydrate vs. a conventional low fat diet to reduce hepatic steatosis [ Time Frame: 8-9 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: April 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

The obesity epidemic has lead to increased morbidity and morality from cardiovascular disease and Type 2 diabetes. One co-morbidity of obesity is nonalcoholic fatty liver disease (NAFLD), which is characterized by excess fat deposition in the liver. About a third of the overweight and obese population has NAFLD and this rises to 80 to 90% of morbidity in obese patients. Short-term weight loss and caloric restriction leads to a reduction in hepatic fat content, suggesting an ability of the liver to quickly respond to dietary interventions. Manipulation of the diet macronutrient composition in order to achieve quicker weight loss as well as improve adverse metabolic consequences attributable to excess weight has attracted much attention and controversy. Multiple clinical studies have shown that low carbohydrate diets can provide more rapid weight loss in individuals in the short-term and that most have no trouble adhering to the diet for up to 6 months. Most bariatric surgery programs use a conventional low fat, calorie restricted diet during the preparation phase for surgery. However, no systematic comparison of diets with different macronutrient compositions have been performed. In this study we propose to compare the clinical effects of a low carbohydrate versus a low fat diet in individuals which can derive an immediate benefit from interventions that have the potential to reduce hepatic fat content: individuals that are preparing for bariatric surgery (laparoscopic Roux-en-Y gastric bypass surgery or adjustable laparoscopic gastric banding). Enlarged steatotic livers increase the operative risk of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduce operative risk. We hypothesize that the use of a 1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake) during the preparation phase for bariatric surgery will cause a greater reduction in weight, hepatic fat content and hepatic volume compared to a "conventional" 1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake) and offer clinical advantages by making the technical aspects of surgery easier. Thus, the data collected will provide significant new clinical insights into the effect of diets with different macronutrient composition. These results will provide a basis for larger clinical trials to identify 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00887393

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Elif A Oral, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Elif Oral, Assoc. Prof. Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00887393     History of Changes
Other Study ID Numbers: MCRU 2462
Study First Received: April 22, 2009
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
morbid obesity
non-alcoholic fatty liver disease
bariatric surgery
low fat diet
low carbohydrate diet

Additional relevant MeSH terms:
Fatty Liver
Obesity
Obesity, Morbid
Liver Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014