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



Status:Archived
Conditions:Obesity Weight Loss, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:April 2009
End Date:September 2010

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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.


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.


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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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