Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 2:17 AM
Study NCT ID:
NCT00887393
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: