Insulin Variance Throughout the Day

Sponsor

Jeffrey Gimble (Other)

Overall Status

Unknown status

CT.gov ID

NCT01546545

Collaborator

Jenny Craig, Inc. (Industry)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to determine whether a person's sensitivity to their own insulin varies from the morning to the evening.

Condition or Disease	Intervention/Treatment	Phase
Insulin Sensitivity

Detailed Description

Study visit 1: about 16 hours - you will come to this visit fasting.

You will have an oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in your arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before you will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after you consume the drink.

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Enrollment Group Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes.

Outcome Measures

Primary Outcome Measures

Evaluating change in insulin sensitivity between morning and evening [24 hours]
This study designed to determine whether a person's sensitivity to their own insulin varies from the morning to the evening. The test is useful in the diagnosis of diabetes, and pre diabetes. Oral Glucose Testing 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. Once the participant drink a glucose-rich beverage, Blood will be drawn at different points and tested to see how effective the body breaks down metabolizes blood glucose.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

Jeffrey Gimble
Jenny Craig, Inc.

Investigators

Principal Investigator: Jeffrey Gimble, MD, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey Gimble, Principal Investigator, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT01546545

Other Study ID Numbers:

PBRC11021

First Posted:

Mar 7, 2012

Last Update Posted:

Dec 17, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Dec 17, 2012