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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01083992
• Other study ID #: NAFLD+ Vitamin D
• Status: Not yet recruiting
• Phase: N/A
• First received: March 8, 2010
• Last updated: April 27, 2011
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2010
• Source: Ziv Hospital
• Contact: Assy Nimer, MD
• Phone: +97246828445
• Email: ASSY.N[@]ZIV.HEALTH.GOV.IL
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Galvus (vitagliptin)
Galvus (vitagliptin)
• Galvus + vitamin D
Galvus + vitamin D

Locations

Country	Name	City	State
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in histological findings	decrease in histological findings: decrease in fat concentration and fibrosis degree	6 months	No