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A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperinsulinemic-hypoglycemic clamp | Procedure | Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Epinephrine Levels | This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure | 90 minute interval following initiation of insulin infusion |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Glucose | This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure | 90 minute interval following initiation of insulin infusion |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll up to 8 healthy men or women (goal n=3 completers) in this method development study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808-4124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure |
| 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 | Peak Epinephrine Levels | This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure | Posted | Mean | Standard Deviation | pg/mL | 90 minute interval following initiation of insulin infusion |
|
|
3 days
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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 | Intervention | Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David McDougal | Pennington Biomedical Research Center | 2257630278 | DAVID.MCDOUGAL@PBRC.EDU |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2018 | Jul 23, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fasting blood glucose | Overnight fasting blood glucose at screening | Mean | Standard Deviation | mg/dL |
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| Secondary | CGM Glucose | This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure | Posted | Mean | Standard Deviation | mg/dL | 90 minute interval following initiation of insulin infusion |
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| 0 |
| 4 |
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| 4 |
| 0 |
| 4 |
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