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

Primary Purpose

Morbid Obesity, Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low carbohydrate diet
low-fat diet
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, non-alcoholic fatty liver disease, bariatric surgery, low fat diet, low carbohydrate diet

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low carbohydrate

Low fat

Arm Description

Low carbohydrate pre-bariatric surgery diet

Low fat pre-bariatric surgery diet

Outcomes

Primary Outcome Measures

Determine the efficacy of a low carbohydrate vs. a conventional low fat diet to reduce hepatic steatosis
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

Secondary Outcome Measures

Full Information

First Posted
April 22, 2009
Last Updated
June 17, 2013
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00887393
Brief Title
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
Official Title
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Non-alcoholic Fatty Liver Disease
Keywords
morbid obesity, non-alcoholic fatty liver disease, bariatric surgery, low fat diet, low carbohydrate diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate
Arm Type
Other
Arm Description
Low carbohydrate pre-bariatric surgery diet
Arm Title
Low fat
Arm Type
Other
Arm Description
Low fat pre-bariatric surgery diet
Intervention Type
Other
Intervention Name(s)
low carbohydrate diet
Intervention Description
1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake)
Intervention Type
Other
Intervention Name(s)
low-fat diet
Intervention Description
1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake)
Primary Outcome Measure Information:
Title
Determine the efficacy of a low carbohydrate vs. a conventional low fat diet to reduce hepatic steatosis
Time Frame
8-9 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif A Oral, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.umms.med.umich.edu/engage/detail_pub_study.do?show=YES&id=3631&TYPE=F
Description
University of Michigan Engage website

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

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