Fatty Liver Study in Patients With Type II Diabetes

NCT ID: NCT02365233

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2016-12-31

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.

Conditions

Type II Diabetes; Nonalcoholic Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thiazolidinedione

(Pioglitazone, 15 mg/day)

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

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

Lantus Insulin

0.35 U per kg body weight once daily

Group Type: ACTIVE_COMPARATOR

Lantus insulin

Intervention Type: DRUG

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

DPP4 inhibitor

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

Group Type: ACTIVE_COMPARATOR

DPP4 inhibitor

Intervention Type: DRUG

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

Interventions

DPP4 inhibitor

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

Pioglitazone

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

Lantus insulin

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

Other Intervention Names

sitagliptin100 mg daily; saxagliptin 5 mg daily; Pioglitazone 15 mg daily; Lantus insulin (0.35U/kg of body weight once daily)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Abate, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch-Galveston

Locations

University of Texas Medical Branch -Galveston

Galveston, Texas, United States

Countries

United States

Other Identifiers

13-021

Identifier Type: -

Identifier Source: org_study_id