Back to results

Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional trial for Nonalcoholic Fatty Liver Disease focused on measuring nonalcoholic fatty liver disease, Pulse wave velocity, augmentation index, metformin

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study.

Exclusion Criteria:

Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study.
Patients with unbalanced endocrine disease or any disease that might affect absorption of medications.
Patients with plasma creatinine > 1.5 mg/dl, and electrolyte abnormalities.

Sites / Locations

Wolfson Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin, Adiponectine, Arterial Compliance

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01084486

First Posted

March 9, 2010

Last Updated

March 9, 2010

Sponsor

Wolfson Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01084486

Brief Title

Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Wolfson Medical Center

4. Oversight

5. Study Description

Brief Summary

Abstract Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes. Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Fatty Liver Disease

Keywords

nonalcoholic fatty liver disease, Pulse wave velocity, augmentation index, metformin

7. Study Design

Study Phase

Phase 1, Phase 2

8. Arms, Groups, and Interventions

Arm Title

Metformin, Adiponectine, Arterial Compliance

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Metformin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study. Exclusion Criteria: Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study. Patients with unbalanced endocrine disease or any disease that might affect absorption of medications. Patients with plasma creatinine > 1.5 mg/dl, and electrolyte abnormalities.

Facility Information:

Facility Name

Wolfson Medical Center

City

Holon

ZIP/Postal Code

58100

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

26198758

Citation

Sofer E, Shargorodsky M. Effect of metformin treatment on circulating osteoprotegerin in patients with nonalcoholic fatty liver disease. Hepatol Int. 2016 Jan;10(1):169-74. doi: 10.1007/s12072-015-9649-6. Epub 2015 Jul 22.

Results Reference

derived

PubMed Identifier

22676459

Citation

Shargorodsky M, Omelchenko E, Matas Z, Boaz M, Gavish D. Relation between augmentation index and adiponectin during one-year metformin treatment for nonalcoholic steatohepatosis: effects beyond glucose lowering? Cardiovasc Diabetol. 2012 Jun 7;11:61. doi: 10.1186/1475-2840-11-61.

Results Reference

derived

PubMed Identifier

21411114

Citation

Sofer E, Boaz M, Matas Z, Mashavi M, Shargorodsky M. Treatment with insulin sensitizer metformin improves arterial properties, metabolic parameters, and liver function in patients with nonalcoholic fatty liver disease: a randomized, placebo-controlled trial. Metabolism. 2011 Sep;60(9):1278-84. doi: 10.1016/j.metabol.2011.01.011. Epub 2011 Mar 15.

Results Reference

derived

Learn more about this trial

Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

We'll reach out to this number within 24 hrs