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

NCT ID: NCT01083992

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galvus + vitamin D

Galvus in combination with vitamin D

Group Type: OTHER

Galvus + vitamin D

Intervention Type: DRUG

Galvus + vitamin D

Galvus

vitagliptin as monotherapy

Group Type: OTHER

Galvus (vitagliptin)

Intervention Type: DRUG

Galvus (vitagliptin)

Interventions

Galvus (vitagliptin)

Galvus (vitagliptin)

Intervention Type: DRUG

Galvus + vitamin D

Galvus + vitamin D

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ziv medical center

Principal Investigators

Nimer Assy, MD

Role: PRINCIPAL_INVESTIGATOR

ZIV MEDICAL CENTER, SAFED ISRAEL

ASSY NIMER, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv medical center safed, israel

Locations

Ziv medical center liver unit

Safed, Israel, , Israel

Countries

Israel

Central Contacts

Assy Nimer, MD

Role: CONTACT

ASSY.N@ZIV.HEALTH.GOV.IL

+97246828445

Facility Contacts

Nimer Assy, MD

Role: primary

assy.n@ziv.health.gov.il

+972-46828445

Other Identifiers

NAFLD+ Vitamin D

Identifier Type: -

Identifier Source: org_study_id