Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
1 other identifier
interventional
60
1 country
1
Brief Summary
Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong relationship between insulin resistance and NAFLD suggests that adding Vitamin D TO insulin sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid metabolism, we assume that adding vitamin D to Galvus, may be effective for NAFLD by improving lipid metabolism and by improving type 2 diabetes mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 28, 2011
March 1, 2010
9 months
March 8, 2010
April 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decrease in histological findings
decrease in histological findings: decrease in fat concentration and fibrosis degree
6 months
Study Arms (2)
Galvus + vitamin D
OTHERGalvus in combination with vitamin D
Galvus
OTHERvitagliptin as monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- years old
- Men and women with NAFLD per US
- Increased ALT level
- Hepatomegaly
- Liver biopsy within 2 years
You may not qualify if:
- Other liver diseases (HBV, HCV)
- Hepatocellular carcinoma
- Decompensated liver disease
- Use of steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Study Sites (1)
Ziv medical center liver unit
Safed, Israel, 13100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimer Assy, MD
ZIV MEDICAL CENTER, SAFED ISRAEL
- PRINCIPAL INVESTIGATOR
ASSY NIMER, MD
Ziv medical center safed, israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 10, 2010
Study Start
April 1, 2012
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
April 28, 2011
Record last verified: 2010-03