NCT05181514|Completed
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Sponsor study identifier
interventional
12
1 country
1
Study Start
April 30, 2019
Actual (reported)Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 1, 2021
Actual (reported)The investigators aim to evaluate whether and to what extent glucose tolerance, beta cell function, insulin clearance, and glucose metabolic fluxes change in response to an acute increase in plasma triglycerides during lipid infusion, independently of free fatty acid (FFA) levels, in nondiabetic subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2019
Actual (reported)December 1, 2021
Actual (reported)December 1, 2021
Actual (reported)December 6, 2021
Actual (reported)January 6, 2022
Actual (reported)Glucose control
Incremental area under the curve (AUC) of plasma glucose in response to the oral glucose tolerance test (OGTT)
At the end of the 5-hour lipid infusion
Insulin secretion
Insulin secretion rate (ISR) estimated from C-peptide deconvolution at fasting and in response to the oral glucose tolerance test (OGTT)
At the end of the 5-hour lipid infusion
Beta cell glucose sensitivity
Beta cell glucose sensitivity calculated by mathematical modeling of insulin secretion rate (ISR) and plasma glucose concentrations during the oral glucose tolerance test (OGTT)
At the end of the 5-hour lipid infusion
Insulin sensitivity
Insulin sensitivity estimated by an OGTT-derived surrogate index (Matsuda index)
At the end of the 5-hour lipid infusion
Insulin clearance
Insulin clearance calculated as the ratio between insulin secretion rate (ISR) and plasma insulin levels
At the end of the 5-hour lipid infusion
Participants will undergo a dual labeled, 3-h oral glucose tolerance test (OGTT) during i.v. infusion of normal saline
Participants will undergo a dual labeled, 3-h oral glucose tolerance test (OGTT) during i.v. infusion of Intralipid 20%.
Participants will receive a 5 h primed (375 mL/m2)-continuous (25 mL h-1 m-2) i.v. infusion of 20% fat emulsion (Intralipid 20%), together with a 5 h primed (28 µmol/kg)-continuous (0.28 µmol min-1 kg-1) infusion of 6,6-\[2H2\]glucose. After 2 h, participants will consume within 5 min an oral glucose drink consisting of 147 mL of 50% dextrose solution (wt/vol) enriched with 1.5 g of \[U-13C\] glucose.
Participants will receive a 5 h primed (375 mL/m2)-continuous (25 mL h-1 m-2) i.v. infusion of normal saline (Sodium Chloride 0.9%), together with a 5 h primed (28 µmol/kg)-continuous (0.28 µmol min-1 kg-1) infusion of 6,6-\[2H2\]glucose. After 2 h, participants will consume within 5 min an oral glucose drink consisting of 147 mL of 50% dextrose solution (wt/vol) enriched with 1.5 g of \[U-13C\] glucose.
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56127, Italy
Andrea Natali, MD
University of Pisa
12 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2021
First Posted
January 6, 2022
Study Start
April 30, 2019
Actual (reported)Rate of oral glucose appearance (RaO)
The rate of oral glucose appearance (RaO) will be assessed from the time course of the plasma tracer/tracee ratio of 6,6-\[2H2\]glucose and \[U-13C\]glucose
At the end of the 5-hour lipid infusion
Endogenous glucose production (EGP)
The endogenous glucose production (EGP) will be assessed from the time course of the plasma tracer/tracee ratio of 6,6-\[2H2\]glucose and \[U-13C\]glucose
At the end of the 5-hour lipid infusion
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Contact the study team to confirm eligibility.
Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 1, 2021
Actual (reported)Last Updated
January 6, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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