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

NCT01084486 | Completed Phase 1

• 1 other identifier: WolfsonMC-2007-9
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

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

Study Arms (1)

Metformin, Adiponectine, Arterial Compliance

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin DRUG

Metformin, Adiponectine, Arterial Compliance

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

Related Publications (3)

• 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.

  PMID: 26198758 DERIVED

• 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.

  PMID: 22676459 DERIVED

• 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.

  PMID: 21411114 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

IL (1)