Insulin Variance Throughout the Day

Completed

• Conditions: Insulin Sensitivity

• Registration Number: NCT01546545
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-02-24
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2016-10-11
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Results First Posted: 2024-03-07
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT	24 hours	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.
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM	24 hours	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.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States