Stable Isotope Metabolic Assessments
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Glucose Production & Insulin Sensitivity
Fasting endogenous glucose production, hepatic insulin sensitivity, and peripheral insulin sensitivity can be assessed simultaneously using a primed-continuous infusion of stable isotope labeled glucose in combination with a hyperinsulinemic-euglycemic clamp.
Gluconeogenesis & Glycogenolysis
The contribution of gluconeogenesis and glycogenolysis to fasting endogenous glucose production can be quantified using primed-continuous infusions of stable isotope labeled glycerol and glucose and the use of mass isotopomer distribution analysis (MIDA).
Postprandial Glucose Fluxes
Postprandial glucose fluxes, such as intestinal glucose absorption, suppression of endogenous glucose production, and total glucose disposal, can be assessed during an oral glucose tolerance test (OGTT) or a mixed meal using a dual stable isotope tracer approach and non-steady-state Steele calculations.
Whole-Body Glycolytic Disposal
Whole-body glycolytic disposal of oral glucose during an OGTT or a mixed meal can be determined using oral administration of deuterated glucose and the measurement of deuterated water in blood. This method can be combined with the dual tracer method described above.
Hepatic De Novo Lipogenesis
Hepatic de novo lipogenesis (DNL) is an important pathway reflecting metabolic health and a useful pharmacodynamic marker for certain therapeutic targets of obesity, diabetes and fatty liver disease. DNL can be assessed using a variety of stable isotope methodologies (13C acetate or deuterated water) and can be combined with measurements such as cholesterol synthesis, bile acid synthesis, and triglyceride synthesis.
Whole-body lipolysis is the catabolic process leading to the breakdown of triglycerides stored in fat cells and can be quantified by measuring the glycerol appearance rate in the fasting state and during a hyperinsulinemic-euglycemic clamp using a stable isotope labeled glycerol infusion.
The assessment of lipoprotein fluxes to understanding mechanism of lipid lowering of novel agents in early clinical studies can be assessed using stable isotope labeled leucine or deuterated water.
Total Energy Expenditure
Total energy expenditure in free-living humans can be measured using the doubly labeled water (DLW) method.
Total Body Water & Body Composition
Total body water and body composition can be determined using a single oral bolus stable isotope labeled water.
Case study – Dual tracer study
A mid-cap pharmaceutical company sought out ProSciento to manage all aspects of a complicated dual tracer phase 1 diabetes study.
With a short timeline, and a limited budget, ProSciento ordered the raw tracer material: [1-13C] sodium acetate, and [6,6-2H2] glucose, and successfully completed the following:
- Managed seven vendors: three specialty suppliers, three specialty tabs, and one contract manufacturing organization
- Helped to manage the manufacturing proposal, the batch record, quality assurance/quality control, certificate of analysis, etc. as there was no commercial tracer solution available
- Compounded the tracers separately in ProSciento’s USP 797 clean room using a 28-step sterile procedure
- Used cold chain shipment logistics for tracer drug sample collection
- Developed an assay to analyze the samples
- Created a detailed drug manual
- Submitted a final report and managed tracer material destruction
To discuss how advanced imaging can be utilized for your customized clinical research program, contact us at firstname.lastname@example.org.