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Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083992
First Posted: March 10, 2010
Last Update Posted: April 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ziv Hospital
  Purpose
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).

Condition Intervention
Non-Alcoholic Fatty Liver Disease Drug: Galvus (vitagliptin) Drug: Galvus + vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • decrease in histological findings [ Time Frame: 6 months ]
    decrease in histological findings: decrease in fat concentration and fibrosis degree


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Galvus + vitamin D
Galvus in combination with vitamin D
Drug: Galvus + vitamin D
Galvus + vitamin D
Galvus
vitagliptin as monotherapy
Drug: Galvus (vitagliptin)
Galvus (vitagliptin)

Detailed Description:
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 T2DM. Methods: 60 patients with NAFLD (Diagnosed by Ultrasound, increase ALT level and hepatomegaly) will be enrolled, and divided into 2 arms Galvus plus Vitamin D vs. Galvus alone. Biochemistry, hepatic triglycerides, histology, m RNA gene expression of collagen, MTP, SREP-1, PPAR-alpha, and LDLR will be measured. 2 separate liver biopsies will be performed at screening and 6 months from baseline. Expected results: Long-term combination therapy with vitagliptin and Vitamin D significantly reduced steatosis, inflammation and fibrosis in the liver compared with long-term monotherapy. We expect also that the combination therapy also significantly increased the expression of microsomal triglyceride transfer protein (MTP) and peroxisome proliferators-activated receptor-α1 (PPAR-α1) in the liver, compared with monotherapy, which may have lead to the improvement in lipid metabolic disorder . Conclusion: Combination therapy of vitagliptin and vitamin D, for 24 weeks improve the histopathology findings in NAFLD.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years old
  • Men and women with NAFLD per US
  • Increased ALT level
  • Hepatomegaly
  • Liver biopsy within 2 years

Exclusion Criteria:

  • Other liver diseases (HBV, HCV)
  • Hepatocellular carcinoma
  • Decompensated liver disease
  • Use of steroids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083992


Contacts
Contact: Assy Nimer, MD +97246828445 ASSY.N@ZIV.HEALTH.GOV.IL

Locations
Israel
Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Contact: Nimer Assy, MD    +972-46828445    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Nimer Assy, MD ZIV MEDICAL CENTER, SAFED ISRAEL
Principal Investigator: ASSY NIMER, MD Ziv medical center safed, israel
  More Information

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01083992     History of Changes
Other Study ID Numbers: NAFLD+ Vitamin D
First Submitted: March 8, 2010
First Posted: March 10, 2010
Last Update Posted: April 28, 2011
Last Verified: March 2010

Keywords provided by Ziv Hospital:
NAFLD
Galvus
vitamin D

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Vitamins
Vitamin D
Ergocalciferols
Vildagliptin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents