NCT02457286

Brief Summary

Metformin is being compared to exercise and diet modifications. The researchers are interested in learning if the addition of metformin to lifestyle modifications is more helpful in treating the condition or disorder. Although metformin is FDA approved to treat type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver (NAFLD) and is considered investigational for the purpose of this study.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

May 14, 2015

Last Update Submit

July 26, 2017

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

  • Improvement in NAFLD as measured by ALT levels

    The primary endpoint variable is the improvement in NAFLD after 12 months of treatment, as measured by the change in ALT levels from baseline to the end of a one year follow-up. A decrease of at least 25% from baseline will be considered a clinically relevant response.

    12 Months

Secondary Outcomes (2)

  • Incidence of metabolic syndrome (insulin resistance)

    12 months

  • Incidence of NAFLD fibrosis scores after 12 months of treatment as measured by Fibroscan

    12 months

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin is being compared to exercise and diet modifications. The study will be incorporating the use of a Fibroscan device (Echosens) at the initial visit and upon completion of the study, which works by measuring shear wave velocity. In this technique, a 50-MHz wave is passed into the liver from a small transducer on the end of an ultrasound probe

Drug: MetforminBehavioral: Lifestyle modificationsDevice: Fibroscan device (Echosens)

Lifestyle modification

EXPERIMENTAL

The researchers are interested in learning if the addition of metformin to lifestyle modifications is more helpful in treating participants condition or disorder. The study will be incorporating the use of a Fibroscan device (Echosens) at the initial visit and upon completion of the study, which works by measuring shear wave velocity. In this technique, a 50-MHz wave is passed into the liver from a small transducer on the end of an ultrasound probe

Behavioral: Lifestyle modificationsDevice: Fibroscan device (Echosens)

Interventions

MetforminDRUG

Although metformin is FDA approved to treat type 2 diabetes, it is not FDA approved for the treatment of NAFLD and is considered investigational for the purpose of this study.

Also known as: Glucophage
Metformin
Lifestyle modificationsBEHAVIORAL

Recommendations for lifestyle modification will be based on the Diabetes Prevention Program 2002 (26) and will include recommendations for greater than 150 minutes of physical activity weekly, referrals to group and/or individualized sessions with nutritionists and/or lifestyle coaches as well as educational materials

Lifestyle modificationMetformin
Fibroscan device (Echosens)DEVICE

This study will be incorporating the use of a Fibroscan device (Echosens) at the initial visit and upon completion of the study, which works by measuring shear wave velocity.

Lifestyle modificationMetformin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects between ages 18-80
  • diagnosed with NAFLD by alanine aminotransferase
  • (ALT) levels \>1.5x the upper limit of normal with an otherwise nondiagnostic hepatic serology workup, ultrasound evidence, and/or histologically confirmed NAFLD within the past 1 year.
  • The upper limit of normal for ALT will be defined as 35 U/L in males and 19 U/L in females

You may not qualify if:

  • A prior history of diabetes
  • Failure to meet criteria for HbA1C screening
  • Evidence of hepatic disorders
  • Use of insulin or oral hypoglycemic agents
  • eGFR \<30
  • Blood transfusion within past 3 months
  • Steroid use in the past 6 months
  • Excessive alcohol use (more than 20g per day in women and more than 30g per day in men)
  • Acute or unstable congestive heart failure
  • Age \>80 years old
  • Lactic acidosis
  • Inability to consent due to cognitive impairment.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (6)

  • Ortiz-Lopez C, Lomonaco R, Orsak B, Finch J, Chang Z, Kochunov VG, Hardies J, Cusi K. Prevalence of prediabetes and diabetes and metabolic profile of patients with nonalcoholic fatty liver disease (NAFLD). Diabetes Care. 2012 Apr;35(4):873-8. doi: 10.2337/dc11-1849. Epub 2012 Feb 28.

    PMID: 22374640RESULT

  • Arase Y, Suzuki F, Ikeda K, Kumada H, Tsuji H, Kobayashi T. Multivariate analysis of risk factors for the development of type 2 diabetes in nonalcoholic fatty liver disease. J Gastroenterol. 2009;44(10):1064-70. doi: 10.1007/s00535-009-0091-1. Epub 2009 Jun 17.

    PMID: 19533014RESULT

  • Bedogni G, Miglioli L, Masutti F, Tiribelli C, Marchesini G, Bellentani S. Prevalence of and risk factors for nonalcoholic fatty liver disease: the Dionysos nutrition and liver study. Hepatology. 2005 Jul;42(1):44-52. doi: 10.1002/hep.20734.

    PMID: 15895401RESULT

  • Adams LA, Waters OR, Knuiman MW, Elliott RR, Olynyk JK. NAFLD as a risk factor for the development of diabetes and the metabolic syndrome: an eleven-year follow-up study. Am J Gastroenterol. 2009 Apr;104(4):861-7. doi: 10.1038/ajg.2009.67. Epub 2009 Mar 17.

    PMID: 19293782RESULT

  • Nar A, Gedik O. The effect of metformin on leptin in obese patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease. Acta Diabetol. 2009 Jun;46(2):113-8. doi: 10.1007/s00592-008-0067-2. Epub 2008 Oct 7.

    PMID: 18839053RESULT

  • Lidofsky SD. Nonalcoholic fatty liver disease: diagnosis and relation to metabolic syndrome and approach to treatment. Curr Diab Rep. 2008 Feb;8(1):25-30. doi: 10.1007/s11892-008-0006-1.

    PMID: 18366995RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • David Bernstein, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Hepatology Center for Liver Diseases

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 29, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 28, 2017

Record last verified: 2016-07

Locations

US(1)