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Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
Effect of Exenatide Treatment on Hepatic Fat Content and Plasma Adipocytokine Levels in Patients With Type 2 Diabetes Mellitus
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•Liver fat content, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients must range in age from 30 to 70 years.
2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
3. 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.
4. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
5. 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.
6. Patients must have Hematocrit greater than 34%.
7. 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.
2. Fasting plasma glucose greater than 260 mg/dl.
3. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
4. 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.
5. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
6. Patients taking medications that affect gastrointestinal motility will be excluded
7. Patients with a history of Congestive Heart failure (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
MASH / liver
1 endpointHepatic Fat
Time frame:one year
Liver fat content, change
change from baseline, improvement
Posted result
| Group | Value (mean), percent of liver fat | 95% CI |
|---|---|---|
| Pioglitazone and Exenatide | 4.7 | — |
| Pioglitazone | 6.5 | — |
Cardiometabolic biomarkers
1 endpointPlasma Adipocytokines
Time frame:one year
Adiponectin, change
change from baseline, improvement
Posted result
| Group | Value (mean), microgram per ml | 95% CI |
|---|---|---|
| Pioglitazone and Exenatide | 23.2 | — |
| Pioglitazone | 15.8 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetologia2011 Dec (month)PMID21956711doi:10.1007/s00125-011-2317-zvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.