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Completed

NCT Number: NCT05181514

Impact of Plasma Lipids on β Cell Function and Insulin Sensitivity

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

About this study

Mild hypertriglyceridemia is associated with reduced glucose tolerance and increased risk of type 2 diabetes, independent of obesity, in both cross-sectional and prospective studies. It is unclear whether this association is direct or mediated by circulating lipid substrates of triglycerides (free fatty acids, or FFA) and which are the mechanisms involved.

To comprehensively examine the effects of mild acute hypertriglyceridemia on major glucose homeostatic mechanisms involved in diabetes progression, two dual-labeled oral glucose tolerance tests (OGTT) during 5-hour intravenous infusions of either 20% Intralipid or normal saline will be performed in healthy lean volunteers. Lipid-induced changes in glucose tolerance and insulin metabolism will be evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-65 years
  • Body mass index (BMI) 18-35 kg/m2
  • both women and men

Exclusion criteria

  • chronic or acute diseases
  • any medications
  • pregnancy

Treatment and study plan

20% Intralipid

Other

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.

Normal Saline

Other

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.

Primary outcomes

  1. Glucose control

    Time frame: At the end of the 5-hour lipid infusion

    Incremental area under the curve (AUC) of plasma glucose in response to the oral glucose tolerance test (OGTT)

  2. Insulin secretion

    Time frame: At the end of the 5-hour lipid infusion

    Insulin secretion rate (ISR) estimated from C-peptide deconvolution at fasting and in response to the oral glucose tolerance test (OGTT)

  3. Beta cell glucose sensitivity

    Time frame: At the end of the 5-hour lipid infusion

    Beta cell glucose sensitivity calculated by mathematical modeling of insulin secretion rate (ISR) and plasma glucose concentrations during the oral glucose tolerance test (OGTT)

  4. Insulin sensitivity

    Time frame: At the end of the 5-hour lipid infusion

    Insulin sensitivity estimated by an OGTT-derived surrogate index (Matsuda index)

  5. Insulin clearance

    Time frame: At the end of the 5-hour lipid infusion

    Insulin clearance calculated as the ratio between insulin secretion rate (ISR) and plasma insulin levels

  6. Rate of oral glucose appearance (RaO)

    Time frame: At the end of the 5-hour lipid infusion

    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

  7. Endogenous glucose production (EGP)

    Time frame: At the end of the 5-hour lipid infusion

    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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2022
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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