Insulin Variance Throughout the Day

Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity

Detailed Description

Study visit 1: about 16 hours - The participant will arrive to the visit fasting.

The participant will have an oral glucose tolerance test which takes about 3 ½ hours.

An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink.

The participant will have a second oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant drinks a sugar solution. Blood will be drawn at specific times after the participant consumes the drink.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

• Study Contact: Name: Tance Sonnier, BS; Phone Number: 225-763-2623; Email: Tance.Sonnier@pbrc.edu
• Study Contact Backup: Name: Jeffrey Gimble, MD, PhD; Phone Number: 225-763-3171; Email: doctors@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants with blood sugar between normal and diabetes.

Description

Inclusion Criteria:

• Are a healthy male or female
• Have a fasting blood sugar that is between normal and diabetes.
• Are between 18 and 70 years of age, inclusive.

Exclusion Criteria:

• Are pregnant or breast-feeding a child
• Take a medication for diabetes
• Take a medication like cortisone that can change your blood sugar.
• Take a medication chronically that has not been at a stable dose for at least 1 month
• Take medication for psychosis that is known to change timing in the day - night cycle

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Insulin Sensitivity in Pre-Diabetic Population; Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM	This study designed to determine whether glucose tolerance varies from the morning to the evening. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and insulin levels. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.	24 hours
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT	This study designed to determine whether insulin levels vary from the morning at 7:00 AM to the evening at 7:00 PM. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and the amount of insulin in the body. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.	24 hours

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Jenny Craig, Inc.
• Investigators: Principal Investigator: Jeffrey Gimble, MD, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimated): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: PBRC 11021