Expired Study
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Fort Sam Houston, Texas 78234


Purpose:

Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.


Criteria:

Inclusion Criteria: - Age 18-70 yrs - DEERS eligible (DoD beneficiary) - All participants must plan to be in the area for at least nine months - Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months Exclusion Criteria: - Alcohol consumption > 20 g/d or history of alcohol abuse - Hepatitis A, B, C - Chronic liver disease of any other etiology - Fatty acid oxidation disorder (Inborn errors of metabolism) - Insulin therapy regime for treatment of diabetes - Pregnancy


Study is Available At:


Original ID:

C.2008.171


NCT ID:

NCT00815009


Secondary ID:


Study Acronym:

NAFLD


Brief Title:

Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease


Official Title:

Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

San Antonio Military Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Overall Contact Information

Official Name:Renee E Cole, MS, PhD
Principal Investigator
San Antonio Military Medical Center

Study Dates

Start Date:October 2008
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 13, 2012
First Received Date:December 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Insulin resistance (IR)
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Mod Fat/Low Processed Carb Diet and Moderate Exerc
Description:Follow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Arm Name:A (Std of Care)
Other Name:Low Carb / Mod Fat
Intervention Type:Behavioral
Name:Low Fat Diet and Moderate Exercise
Description:Follow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Arm Name:B (Low Fat)
Other Name:Low Fat
Intervention Type:Behavioral
Name:Moderate Exercise Only
Description:No special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Arm Name:D (Exercise only)
Other Name:Mod exercise

Study Arms

Study Arm Type:No Intervention
Arm Name:A (Std of Care)
Description:Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).
Study Arm Type:Experimental
Arm Name:B (Low Fat)
Description:Standard of Care, plus Low Fat Diet and Moderate Exercise
Study Arm Type:Experimental
Arm Name:C (Mod Fat)
Description:Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
Study Arm Type:Experimental
Arm Name:D (Exercise only)
Description:Standard of Care plus Moderate Exercise only

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:San Antonio Military Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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