Back to results

Fatty Liver Study in Patients With Type II Diabetes

Primary Purpose

Type II Diabetes, Nonalcoholic Fatty Liver

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

DPP4 inhibitor

Pioglitazone

Lantus insulin

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring Type II Diabetes, Nonalcoholic fatty liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Adults at least 18 years of age at the time of consent.
Have type 2 diabetes mellitus.
Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment.
Have blood A1c >7.6% and < 8.5% within 3 months prior to study enrollment.
Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment.
Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months.
Women of Childbearing Potential must be willing and able to use acceptable forms of birth control while on the study.

Exclusion Criteria:

Currently taking medication that can affect glucose metabolism other than Metformin.
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.
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.
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.
History of heart failure.
Concurrent participation on another research study
Use of an investigational agent in the 30 days prior to signing informed consent.
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.
Females who are pregnant or lactating
Current Diagnosis or History of Bladder Cancer

Sites / Locations

University of Texas Medical Branch -Galveston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Thiazolidinedione

Lantus Insulin

DPP4 inhibitor

Arm Description

(Pioglitazone, 15 mg/day)

0.35 U per kg body weight once daily

Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day

Outcomes

Primary Outcome Measures

Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit

Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.

Secondary Outcome Measures

Full Information

NCT ID

NCT02365233

First Posted

May 9, 2013

Last Updated

July 5, 2018

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT02365233

Brief Title

Fatty Liver Study in Patients With Type II Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

IRB withheld the data due to inadequate supporting documentation

Study Start Date

May 1, 2013 (Actual)

Primary Completion Date

December 31, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Type II Diabetes, Nonalcoholic Fatty Liver

Keywords

Type II Diabetes, Nonalcoholic fatty liver

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thiazolidinedione

Arm Type

Active Comparator

Arm Description

(Pioglitazone, 15 mg/day)

Arm Title

Lantus Insulin

Arm Type

Active Comparator

Arm Description

0.35 U per kg body weight once daily

Arm Title

DPP4 inhibitor

Arm Type

Active Comparator

Arm Description

Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day

Intervention Type

Drug

Intervention Name(s)

DPP4 inhibitor

Other Intervention Name(s)

sitagliptin100 mg daily, saxagliptin 5 mg daily

Intervention Description

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Intervention Type

Drug

Intervention Name(s)

Pioglitazone

Other Intervention Name(s)

Pioglitazone 15 mg daily

Intervention Description

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Intervention Type

Drug

Intervention Name(s)

Lantus insulin

Other Intervention Name(s)

Lantus insulin (0.35U/kg of body weight once daily)

Intervention Description

Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Primary Outcome Measure Information:

Title

Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit

Description

Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.

Time Frame

Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Adults at least 18 years of age at the time of consent. Have type 2 diabetes mellitus. Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment. Have blood A1c >7.6% and < 8.5% within 3 months prior to study enrollment. Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment. Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months. Women of Childbearing Potential must be willing and able to use acceptable forms of birth control while on the study. Exclusion Criteria: Currently taking medication that can affect glucose metabolism other than Metformin. 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. 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. 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. History of heart failure. Concurrent participation on another research study Use of an investigational agent in the 30 days prior to signing informed consent. 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. Females who are pregnant or lactating Current Diagnosis or History of Bladder Cancer

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicola Abate, MD

Organizational Affiliation

University of Texas Medical Branch-Galveston

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch -Galveston

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Fatty Liver Study in Patients With Type II Diabetes

We'll reach out to this number within 24 hrs