NCT04774081

Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will determine whether the ratio between 24h C-peptide urinary excretion rate and average 24h circulating glucose represent a good correlate of what is measured by the gold standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp

Conditions

• Insulin Sensitivity

Interventions

Type	Name	Description
DEVICE	24h Continuous glucose monitoring and urinary C-peptide collection	Participants will be admitted to the research clinic for a 24-hour stay in a metabolic chamber. During the chamber stay, all urine excreted will be collected to assess C-peptide urinary excretion rate and interstitial glucose will be measured by a continuous glucose monitor (CGM). Participants will consume a eucaloric diet (50% carbohydrates, 30% fat and 20% protein).

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-02-21
• Completion: 2022-02-21
• First posted: 2021-02-26
• Last updated: 2022-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study