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Insulin Variance Throughout the Day

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Pennington Biomedical Research Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Jenny Craig, Inc.
Information provided by (Responsible Party):
Jeffrey Gimble, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01546545
First received: February 24, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose
This study is designed to determine whether a person's sensitivity to their own insulin varies from the morning to the evening.

Condition
Insulin Sensitivity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Evaluating change in insulin sensitivity between morning and evening [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Enrollment Group
Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Jeffrey Gimble, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01546545     History of Changes
Other Study ID Numbers: PBRC11021 
Study First Received: February 24, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016