Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 368817 for:    ALL
Previous Study | Return to List | Next Study

Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study (CGM-PEPTIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774081
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Ravussin, 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

Condition or disease Intervention/treatment
Insulin Sensitivity Device: 24h Continuous glucose monitoring and urinary C-peptide collection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Study group
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
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).




Primary Outcome Measures :
  1. Glycemia (Continuous Glucose Monitoring) [ Time Frame: 24 hours ]
  2. Urinary C-peptide [ Time Frame: 24 hours ]

Other Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774081


Contacts
Layout table for location contacts
Contact: Eric Ravussin, PhD 225-763-3186 eric.ravussin@pbrc.edu

Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Eric Ravussin, PhD    225-763-2602    Doctors@pbrc.edu   
Principal Investigator: Eric Ravussin, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
Layout table for additonal information
Responsible Party: Eric Ravussin, Boyd Professor, Associate Executive Director for Clinical Science, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT04774081    
Other Study ID Numbers: PBRC2020-009
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases