Status:
COMPLETED
Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Insulin Sensitivity
Eligibility:
All Genders
18-65 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04774081
Start Date
February 8 2021
End Date
February 21 2022
Last Update
June 14 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70809