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| Name | Class |
|---|---|
| Jenny Craig, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy participants with blood sugar between normal and diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Gimble, MD, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Circadian Variablity of insulin sensitivity in a pre-diabetic population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mg/dl | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomitting during OGTT | Gastrointestinal disorders | Non-systematic Assessment | One participant got nauseous and vomitted during the Oral Glucose Tolerance Testing. This is an infrequent known side effect of the test. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Gimble, MD, PhD | Pennington Biomedical Research Center | 225-763-3000 | doctors@pbrc.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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IV Blood sample
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Evening OGTT at 7:00 PM | 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. |
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|
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| 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. | Posted | Mean | Standard Deviation | UI*hr/L | 24 hours |
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| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
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