Insulin Variance Throughout the Day

NCT ID: NCT01546545

Last Updated: 2024-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Insulin Sensitivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Insulin Sensitivity in Pre-Diabetic Population

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jenny Craig, Inc.

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Gimble, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 11021

Identifier Type: -

Identifier Source: org_study_id

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