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

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).

Study Overview

• Status: Unknown
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Galvus + vitamin D; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, Israel, 13100
    • Ziv medical center liver unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Galvus + vitamin D; Galvus in combination with vitamin D	Drug: Galvus + vitamin D; Galvus + vitamin D
Other: Galvus; vitagliptin as monotherapy	Drug: Galvus (vitagliptin); Galvus (vitagliptin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease in histological findings	decrease in histological findings: decrease in fat concentration and fibrosis degree	6 months

Collaborators and Investigators

• Sponsor: Ziv Hospital
• Investigators: Principal Investigator: Nimer Assy, MD, ZIV MEDICAL CENTER, SAFED ISRAEL; Principal Investigator: ASSY NIMER, MD, Ziv medical center safed, israel

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2011
• Last Update Submitted That Met QC Criteria: April 27, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: NAFLD; vitamin D; Galvus
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Micronutrients; Vitamins; Bone Density Conservation Agents; Dipeptidyl-Peptidase IV Inhibitors; Vitamin D; Vildagliptin
• Other Study ID Numbers: NAFLD+ Vitamin D