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Role of Exenatide in NASH-a Pilot Study (NAFLD)

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ClinicalTrials.gov Identifier: NCT00650546
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : May 12, 2016
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Nonalcoholic Fatty Liver Disease
Intervention Drug: Exenatide
Enrollment 8
Recruitment Details 2 recruitment sites: Department of Gastroenterology, San Antonio Uniformed Services Health Consortium, San Antonio, Texas, USA. Indiana University School of Medicine, Indianapolis, IN, USA
Pre-assignment Details This was a single arm, open label study. Only study group received exenatide treatment. Eight adult patients with known type 2 DM and biopsy-proven NAFLD were treated with 5-10mcg subcutaneous exenatide for 28 week.All eight patients were started on exenatide 5 mcg injections twice a day and the dose was increased to 10 mcg injections twice a day
Arm/Group Title Exenatide Group
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Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated

Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Open-labeled Prospective Case Series
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Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated

Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day

Overall Number of Baseline Participants 8
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eight adult patients with known type 2 DM and biopsy -proven NAFLD were treated with 5-10 subcutaneous exenatide for 28 weeks
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 8 participants
54
(36 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Number of participants who had NAFLD Activity Score (NAS) pre/post 24-28 wks. after treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants
8
[1]
Measure Description: The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.
NAS score   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
4
(3 to 5)
[1]
Measure Description: steatosis, inflammation, ballooning. Each catagory has a 1 to 3 value given and the total of all 3 catagories equals the NAS overall score. 1] The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease
1.Primary Outcome
Title Number of Patients With Improvement in Liver Histology After Treatment With Exenatide
Hide Description Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS<3.
Time Frame between baseline and 24-28 weeks after initiating treatment
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[Not Specified]
Arm/Group Title Treatment With Exenatide
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eight adult patients with known type 2 DM and biopsy proven NAFLD
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
2.Primary Outcome
Title Change in NAS
Time Frame Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.
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[Not Specified]
Arm/Group Title Individuals Who Recieved Treatment With Exenatide
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change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (1.66)
Time Frame 28 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Group
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Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated

Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day

All-Cause Mortality
Exenatide Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Group
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide Group
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
Gastrointestinal disorders   
abdominal pain along with nausea  1  2/8 (25.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE
As a case series our findings are limited by a control group and a small number of subjects enrolled. These limitations are tempered by the single expert hepatologist and the stringent definitions for histological improvement, ((primary end point)..
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Patrick R Kenney, DO
Organization: Department of Gastroenterology, San Antonio Uniformed Services Health Consortium
Other Publications:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00650546     History of Changes
Other Study ID Numbers: DK61737
U01DK061737 ( U.S. NIH Grant/Contract )
First Submitted: March 28, 2008
First Posted: April 1, 2008
Results First Submitted: August 31, 2015
Results First Posted: May 12, 2016
Last Update Posted: April 11, 2017