Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study (CGM-PEPTIDE)

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

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity
• Intervention / Treatment: Device: 24h Continuous glucose monitoring and urinary C-peptide collection

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited among those whose insulin sensitivity has been previously measured by a high-dose euglycemic-hyperinsulinemic clamp at Pennington Biomedical during the last 5 years and indicated their wiliness to be re-contacted for future research

Description

Inclusion Criteria:

• Healthy male or female
• Age 18-65 y
• BMI between 20 kg/m2 and 35 kg/m2 (inclusive)
• Are willing to consume pre-prepared meals
• Have completed a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp during the last five years at Pennington Biomedical. The data from the previous PBRC clamp will be pulled and used in conjunction with data from this study.
• Willing to have blood and urine stored for future use

Exclusion Criteria:

• Major lifestyle changes since the euglycemic-hyperinsulinemic clamp was performed (i.e. gain/lost weight, stopped smoking, began/stop exercise).
• Unstable weight in the last 3 months [gain or loss >10 lb (or 4.5 kg)]
• Diagnosed with diabetes
• Untreated hypertension and average screening blood pressure >140/90 mmHg
• Previous bariatric surgery (or other surgeries) for obesity or weight loss
• Chronic use of medications affecting metabolism or sleep*
• History of neurological disease
• History of cardiovascular disease, or other chronic diseases, that might affect pancreatic or glucose metabolism.
• Pregnant, planning to become pregnant, or breastfeeding
• Adherence to special restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) over the last 3 months. *Sporadic use of these medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, participants should not be taking the medication for 1-month prior to the first visit.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; Participants will be recruited among those whose insulin sensitivity has been previously measured by a high-dose euglycemic-hyperinsulinemic clamp at Pennington Biomedical during the last 5 years and indicated their wiliness to be re-contacted for future research

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycemia (Continuous Glucose Monitoring)	24 hours
Urinary C-peptide	24 hours

Other Outcome Measures

Outcome Measure	Time Frame
M-value at a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp.	Up to 5 years before the CGM and C-peptide assessment

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ACTUAL): February 21, 2022
• Study Completion (ACTUAL): February 21, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (ACTUAL): February 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Hyperinsulinism; Hypersensitivity; Insulin Resistance
• Other Study ID Numbers: PBRC2020-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No