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

NCT04774081 | Completed FDA Device

• 1 other identifier: PBRC2020-009
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Glycemia (Continuous Glucose Monitoring)

  24 hours

• Urinary C-peptide

  24 hours

Other Outcomes (1)

• M-value at a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp.

  Up to 5 years before the CGM and C-peptide assessment

Study Arms (1)

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

Interventions

24h Continuous glucose monitoring and urinary C-peptide collection 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).

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Boyd Professor, Associate Executive Director for Clinical Science

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: February 8, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)