Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
Conditions
Brief summary
The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.
Interventions
DRUGExenatide
Single subcutaneous injection (10 μg)
OTHERNormal Saline
Single subcutaneous injection
Sponsors
Carl T. Hayden VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT * Fasting triglyceride levels \>140 and \< 400 mg/dl and values varying less than 35% between two screening measurements * Normal liver function tests and white blood cell count
Exclusion criteria
* Type 2 Diabetes for \> 3 years or HbA1c ≥ 7.5 * Known or suspected Type 1 Diabetes * Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin * Creatinine \> 2.0 mg/dl or other evidence of active kidney disease * Hepatic enzyme elevation \> 2x normal * Known Nonalcoholic Fatty Liver Disease * Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems * Recent history of nausea or vomiting * Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks * A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months * Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (\>1 g/day) * Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride concentration in serum | Before and up to 8-hours post-injection |
Secondary
| Measure | Time frame |
|---|---|
| serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function | Before and up to 8 hours post-injection |
Countries
United States
Outcome results
None listed