Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Completed
- Conditions
- Insulin Sensitivity
- Interventions
- Device: 24h Continuous glucose monitoring and urinary C-peptide collection
- Registration Number
- NCT04774081
- Lead Sponsor
- Pennington Biomedical Research Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group 24h Continuous glucose monitoring and urinary C-peptide collection 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
- Primary Outcome Measures
Name Time Method Urinary C-peptide 24 hours Glycemia (Continuous Glucose Monitoring) 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States