Phase 4
Completed N=15
Acute Effect of Exenatide on Brain Glucose Metabolism
Impaired Glucose Tolerance (IGT) · Diabetes
Source: ClinicalTrials.gov NCT01588418 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism — 0.14; 0.10 μmol/(ml*min)
◆ Published Evidence
Established
95citations · ~10 / year
Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study.
Summary
This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.
Linked Publications (2)
-
Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study.
-
Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism |
0.14; 0.10 | — |
| SECONDARY Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males age 18-65 years old
- Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
- 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
- Patients must have BMI of 25-40 kg/m2
- Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
- Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
- Patients must have the following laboratory values:
- Hematocrit ≥ 34 vol%
- Serum creatinine* ≤ 1.5 mg/dl in males and
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
- Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal
- If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min
Exclusion Criteria
Patients are excluded from participation in the study if they meet any of the following criteria:
- Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
- Patients with BMI over 40 and under 25
- Patient with age below 18 yrs and over 65 yrs
- Female subjects
- Patients with type 1 diabetes
- Patients treated for type 2 diabetes
- Subjects with normal glucose tolerance (NGT)
Data sourced from ClinicalTrials.gov (NCT01588418) 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.