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Insulin Variance Throughout the Day

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ClinicalTrials.gov Identifier: NCT01546545
Recruitment Status : Unknown
Verified December 2012 by Jeffrey Gimble, Pennington Biomedical Research Center.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
Jenny Craig, Inc.
Information provided by (Responsible Party):
Jeffrey Gimble, Pennington Biomedical Research Center

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
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 Type : Observational
Estimated 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 : March 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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



Primary Outcome Measures :
  1. Evaluating change in insulin sensitivity between morning and evening [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
IV Blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy participants with blood sugar between normal and diabetes.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546545


Contacts
Contact: Tance Sonnier, BS 225-763-2623 Tance.Sonnier@pbrc.edu
Contact: Jeffrey Gimble, MD, PhD 225-763-3171 doctors@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Jeffrey Gimble, MD, PhD    225-763-3171    jeffrey.gimble@pbrc.edu   
Sponsors and Collaborators
Jeffrey Gimble
Jenny Craig, Inc.
Investigators
Principal Investigator: Jeffrey Gimble, MD, PhD Pennington Biomedical Research Center

Responsible Party: Jeffrey Gimble, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01546545     History of Changes
Other Study ID Numbers: PBRC11021
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases