Insulin Variance Throughout the Day

Insulin Sensitivity Clinical Trial

Official title:

Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546545
• Other study ID #: PBRC 11021
• Status: Completed
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Jenny Craig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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