Phase 4
Completed N=24
Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
Source: ClinicalTrials.gov NCT01432405 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Hepatic Fat — 4.7; 6.5 percent of liver fat
◆ Published Evidence
Highly cited
108citations · ~7 / year
Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial.
Summary
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.
Linked Publications
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Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Fat |
4.7; 6.5 | — |
| SECONDARY Plasma Adipocytokines |
23.2; 15.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01432405) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.