Insulin Variance Throughout the Day

NCT01546545 | Completed Results

• 1 other identifier: PBRC 11021
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

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

  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.

  24 hours

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

  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.

  24 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants with blood sugar between normal and diabetes.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Jenny Craig, Inc.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

IV Blood sample

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Jeffrey Gimble, MD, PhD
• Organization: Pennington Biomedical Research Center

doctors@pbrc.edu

225-763-3000

Study Officials

• Jeffrey Gimble, MD, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2023-08

Locations

US (1)