Trial Outcomes & Findings for Insulin Variance Throughout the Day (NCT NCT01546545)

NCT ID: NCT01546545

Last Updated: 2024-03-07

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 11 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2024-03-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Insulin Variance Throughout the Day

Baseline characteristics by cohort

Measure	Insulin Sensitivity in Pre-Diabetic Population n=10 Participants Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes.
Age, Continuous	53 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI	28.0 kg/m^2 STANDARD_DEVIATION 2.8 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Measure	Morning OGTT at 7:00 AM n=10 Participants Ten subjects with prediabetes completed oral glucose tolerance tests at 7:00 AM and 7:00 PM on the same day. Lipids and hormones were also measured.	Evening OGTT at 7:00 PM n=10 Participants Ten subjects with prediabetes completed oral glucose tolerance tests at 7:00 AM and 7:00 PM on the same day. Lipids and hormones were also measured.
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM	163 mg/dl Standard Deviation 62	203 mg/dl Standard Deviation 71

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Measure	Morning OGTT at 7:00 AM n=10 Participants Ten subjects with prediabetes completed oral glucose tolerance tests at 7:00 AM and 7:00 PM on the same day. Lipids and hormones were also measured.	Evening OGTT at 7:00 PM n=10 Participants Ten subjects with prediabetes completed oral glucose tolerance tests at 7:00 AM and 7:00 PM on the same day. Lipids and hormones were also measured.
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT	69.8 UI*hr/L Standard Deviation 40.2	87.4 UI*hr/L Standard Deviation 37.6

Adverse Events

Insulin Sensitivity in Pre-Diabetic Population

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Sensitivity in Pre-Diabetic Population n=11 participants at risk Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes.
Gastrointestinal disorders Nausea and vomitting during OGTT	9.1% 1/11

Additional Information

Jeffrey Gimble, MD, PhD

Pennington Biomedical Research Center

Phone: 225-763-3000

Email: doctors@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place