Insulin Sensitivity
Conditions
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
Interventions
DEVICE24h 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).
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemia (Continuous Glucose Monitoring) | 24 hours |
| Urinary C-peptide | 24 hours |
Other
| 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 |
Countries
United States
Outcome results
None listed