Insulin Variance Throughout the Day | Clinical Trial

Key information

Conditions

Insulin Sensitivity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM

Time frame: 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.
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

Jenny Craig, Inc.

Registry information

Official study title

Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 7, 2012
Registry last updated: Mar 7, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed