Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication, on liver fat and blood levels of proteins that influence liver fat.

Key facts

Study ID

NCT01432405

Run by

Baylor College of Medicine

People needed

24

Starts

2007-06-01

Expected to finish

2009-06-01

Last updated by the study team

2016-04-12

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must range in age from 30 to 70 years.
• Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
• Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
• Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
• Patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
• Patients must have Hematocrit greater than 34%.
• Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.

You may not qualify if…

• 1, Type 1 diabetes.
• Fasting plasma glucose greater than 260 mg/dl.
• Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
• Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
• Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
• Patients taking medications that affect gastrointestinal motility will be excluded
• Patients with a history of Congestive Heart failure (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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