Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease

NCT00949403 | Completed Early Phase 1 Results DMC

• 1 other identifier: 09-0621
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric bypass surgery.

Conditions

Fatty Liver

Keywords

Non-Alcoholic Fatty Liver disease

Outcome Measures

Primary Outcomes (1)

• Hepatic Fatty Acid Oxidation

  Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.

  3 hours

Study Arms (1)

Obese Females (pre-bariatric surgery)

EXPERIMENTAL

Twenty obese females (18-45 years of age, BMI \> or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years. They will be imaged with PET/CT and radiopharmaceuticals C-11 Acetate and C-11 Palmitate will be injected.

Drug: Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate

Interventions

Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate DRUG

injection of C-11 Palmitate and C-11 Acetate during PET/CT to determine Liver metabolism

Obese Females (pre-bariatric surgery)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese females with a BMI of greater then or equal to 45.
• Age range between 18-45 years.
• Patients undergoing bariatric surgery at Barnes-Jewish Hospital-St.Louis,MO.

You may not qualify if:

• Any prior history or evidence of liver disease other than Non-Alcoholic Fatty liver Disease, severe hypertriglyceridemia and diabetes mellitis.
• Consumed greater then or equal to 20 grams of alcohol per day.
• Taking medications that are known to cause hepatic steatosis \& liver damage.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Limitations and Caveats

there were no limitations or caveats

Results Point of Contact

• Title: Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
• Organization: Washington University School of Medicine

groplerr@mir.wustl.edu

314-747-3877

Study Officials

• Robert J Gropler, MD

  PI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 19, 2011
• Last Updated: June 22, 2020
• Results First Posted: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)