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

Study Overview
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Brief Summary
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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

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

Conditions
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Insulin Sensitivity

Intervention / Treatment
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* Device: 24h Continuous glucose monitoring and urinary C-peptide collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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