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OpenTrials
Completed

NCT Number: NCT04774081

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

24h Continuous glucose monitoring and urinary C-peptide collection

Device

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).

Primary outcomes

  1. Glycemia (Continuous Glucose Monitoring)

    Time frame: 24 hours

  2. Urinary C-peptide

    Time frame: 24 hours

Other outcomes

  1. M-value at a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp.

    Time frame: Up to 5 years before the CGM and C-peptide assessment

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: CGM-PEPTIDE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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