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Phase 4 Completed N=24 Randomized Treatment

Effect of Exenatide on Liver and Heart Fat and Inflammation

Source: ClinicalTrials.gov NCT01951651 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Myocardial Fat Content — 1.7; 1.1 percentage of myocardium content
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The purpose of this study is to examine the effect of exenatide on liver and heart (myocardial) fat and inflammation.

Outcome Measures

OutcomeResultp-value
PRIMARY
Myocardial Fat Content
1.7; 1.1
PRIMARY
Hepatic Fat Content
10.9; 13.1
SECONDARY
Left Ventricular Ejection Fraction (LVEF)(%).
60; 56
SECONDARY
Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)
-65.0; 0.0

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Patients must range in age from 30 to 70 years, inclusive.
  • Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997 Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis of type 2 diabetes mellitus.
  • Patients must be on diet therapy and/or metformin treatment for type 2 diabetes (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl
  • Patients must have Hematocrit greater than 34 vol%.
  • Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

Exclusion Criteria

  • Patients must not have type 1 diabetes.
  • Patients must not have a 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, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01951651). 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.

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