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Fatty Liver Study in Patients With Type II Diabetes | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Fatty Liver Study in Patients With Type II Diabetes

A Phase IV, Open Label, Randomized Trial on the Effect of Metformin Plus Lantus Insulin, Pioglitazone, or DPP4 Inhibitor on Fatty Liver in Patients With Type II Diabetes

NCT02365233•The University of Texas Medical Branch, Galveston

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Detailed Description

In patients with type 2 diabetes whose glycemic control is not accomplished with Metformin alone, there are several options for additional hypoglycemic agent. As per recent National guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, Lantus insulin, and DPP4 inhibitors. All three approaches have been proven to help accomplishing goals of therapy for glycemic control (HbA1c\<7%) in clinical trials. Whether one approach is superior to the other in improving associated non-glycemic metabolic abnormalities and risk for future morbidity and mortality in patients with type 2 diabetes remains a matter of intense debate. Among these abnormalities, excessive triglyceride content in the liver (fatty liver or liver steatosis) is a major predictor of risk for non-alcoholic steato-hepatitis (NASH) and liver cirrhosis. Fatty liver is highly prevalent in patients with type 2 diabetes. There are no clinical studies done to determine if any of these three therapeutic options is superior at reducing the liver triglyceride content in patients with type 2 diabetes and fatty Liver. Therefore, in this study we propose to measure and compare the effects on liver triglyceride content when either pioglitazone, lantus insulin, or DPP4 inhibitors are added to metformin in patients with poorly controlled type 2 diabetes (HbA1c\>7.6%) and fatty liver (presence of "bright" liver in abdominal ultrasound). The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
•2. Adults at least 18 years of age at the time of consent.
•3. Have type 2 diabetes mellitus.
•4. Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment.
•5. Have blood A1c \>7.6% and \< 8.5% within 3 months prior to study enrollment.
•6. Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment.
•7. Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months.
•8. Women of Childbearing Potential must be willing and able to use acceptable forms of birth control while on the study.

Exclusion Criteria

•1. Currently taking medication that can affect glucose metabolism other than Metformin.
•2. History of Kidney diseases that, in the opinion of the investigator , would place the subject at increased risk of participation or plasma levels of creatinine \> 1.4 for women and \> 1.5 for men.
•3. History of Cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion of the investigator, would place the subject at increased risk of participation.
•4. Current alcohol consumption more than12 to 15 g of alcohol a day, or \>12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits.
•5. History of heart failure.
•6. Concurrent participation on another research study
•7. Use of an investigational agent in the 30 days prior to signing informed consent.
•8. History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
•9. Females who are pregnant or lactating
•10. Current Diagnosis or History of Bladder Cancer

Locations (1)

University of Texas Medical Branch -Galveston

Galveston, Texas, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

December 31, 2016

Completion Date

December 31, 2016

Last Updated

July 31, 2018

Enrollment

ACTUAL participants

Conditions

Type II DiabetesNonalcoholic Fatty Liver

Interventions

DPP4 inhibitor

DRUG

Pioglitazone

DRUG

Lantus insulin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fatty Liver Study in Patients With Type II Diabetes

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

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Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity