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

Insulin Sensitivity Clinical Trial

— CGM-PEPTIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774081
• Other study ID #: PBRC2020-009
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: June 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Device:
• 24h 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).

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	M-value at a high-dose (=80 mIU/m2/min) euglycemic-hyperinsulinemic clamp.		Up to 5 years before the CGM and C-peptide assessment
Primary	Glycemia (Continuous Glucose Monitoring)		24 hours
Primary	Urinary C-peptide		24 hours