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

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Galvus + vitamin D; Drug: Galvus (vitagliptin)

• Registration Number: NCT01083992
• Lead Sponsor: Ziv Hospital

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).

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 Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28
• Study Start: 2012-04
• Primary Completion: 2013-01
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galvus + vitamin D	Galvus + vitamin D	Galvus in combination with vitamin D
Galvus	Galvus (vitagliptin)	vitagliptin as monotherapy

Primary Outcome Measures

Name	Time	Method
decrease in histological findings	6 months	decrease in histological findings: decrease in fat concentration and fibrosis degree

Trial Locations

Locations (1)

Ziv medical center liver unit; 🇮🇱 Safed, Israel, Israel