Insulin and Insulin Pulses During Fasting
ConditionPreDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorMayo Clinic
About this trial
Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
people with normal or impaired fasting glucose and normal or impaired glucose tolerance
Disqualifiers
HbA1c > 6.5%
BMI ≥ 35 Kg/M2
Use of any glucose-lowering agents including metformin or sulfonylureas.
For female subjects: positive pregnancy test at the time of enrollment or study
Trial design
Design model
Crossover
Treatments tested in this trial
Intralipid and heparin
Other interventionIntralipid (20%, 0.011ml/kg/min; Baxter, Healthcare, Deerfield, IL) and heparin (200 units prime, 0.2 unit/kg/min continuous) will be infused to induce acute insulin resistance
Saline
Other interventionSaline will be infused
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intralipid and heparinActive comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Suppression of Endogenous glucose production (EGP) by insulin
comparison of EGP in people with IFG vs NFG in response to insulin infusion
Time frame
The rate of EGP at 240 minutes (end of study) expressed as a percentage of fasting EGP (at the start of the study i.e.: 0 minutes.2
Insulin pulse orderliness
comparison of Insulin pulse orderliness measured by approximate entropy in people with IFG vs NFG
Time frame
Approximate Entropy (ApEn) will be calculated from the insulin concentrations observed every 2 minutes between -45 and 0 minutesSponsors and contacts
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Source ClinicalTrials.gov