A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
Status and phase
Completed
Phase 1
Conditions
Diabetes
Treatments
Drug: Stable isotope tracer (13-C(4)-BHB)
Details and patient eligibility
About
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.
Enrollment
24 patients
Sex
Male
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Diagnostic
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
24 participants in 1 patient group
1
Experimental group
Description:
Biomarker evaluation
Treatment:
Drug: Stable isotope tracer (13-C(4)-BHB)
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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