Insulin Sensitivity
Conditions
Brief summary
This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening.
Detailed description
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.
Interventions
None listed
Sponsors
Jenny Craig, Inc.
Pennington Biomedical Research Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM | 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. |
| Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Insulin Sensitivity in Pre-Diabetic Population |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 14 |
| BMI | 28.0 kg/m^2 STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning OGTT at 7:00 AM | 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 |
| Evening OGTT at 7:00 PM | Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT | 87.4 UI*hr/L | Standard Deviation 37.6 |
p-value: 0.02t-test, 2 sided
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning OGTT at 7:00 AM | Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM | 163 mg/dl | Standard Deviation 62 |
| Evening OGTT at 7:00 PM | Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM | 203 mg/dl | Standard Deviation 71 |
p-value: 0.02t-test, 2 sided