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

NCT ID: NCT04774081

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2022-02-21

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

24h Continuous glucose monitoring and urinary C-peptide collection

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Ravussin

Boyd Professor, Associate Executive Director for Clinical Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC2020-009

Identifier Type: -

Identifier Source: org_study_id