Diabetes
Conditions
Brief summary
This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.
Interventions
DRUGStable isotope tracer (13-C(4)-BHB)
A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2 * Subject has been a nonsmoker or has not used nicotine for the past 6 months
Exclusion criteria
* Subject has a history of diabetes mellitus * Subject has a history of stroke, chronic seizures, or other neurological disorder * Subject has a history of cancer, except certain skin cancers * Subject consumes more than 3 alcoholic beverages per day * Subject consumes more than 6 servings of caffeinated beverages per day * Subject has multiple and/or severe allergies to food or drugs * Subject has allergy or sensitivity to eggs or soy * Subject regularly uses illicit drugs or has a history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects | 5 hours |
Secondary
| Measure | Time frame |
|---|---|
| Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects | 5 hours |
Outcome results
None listed