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

NCT00887393 | Completed

• 1 other identifier: MCRU 2462
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Non-alcoholic Fatty Liver Disease

Keywords

morbid obesity; non-alcoholic fatty liver disease; bariatric surgery; low fat diet; low carbohydrate diet

Outcome Measures

Primary Outcomes (2)

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

  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

  8-9 weeks

Study Arms (2)

Low carbohydrate

OTHER

Low carbohydrate pre-bariatric surgery diet

Other: low carbohydrate diet

Low fat

OTHER

Low fat pre-bariatric surgery diet

Other: low-fat diet

Interventions

low carbohydrate diet OTHER

1000 to 1200 kcalorie low carbohydrate diet (\< 15% of total kcaloric intake)

Low carbohydrate

low-fat diet OTHER

1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake)

Low fat

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Non-alcoholic Fatty Liver Disease

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elif A Oral, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Medicine

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)