Diabetes
Conditions
Brief summary
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.
Interventions
PROCEDUREHyperinsulinemic-hypoglycemic clamp
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.
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Inclusion criteria
* Healthy male or female * Ages 18-40 years * BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted) * Medically cleared for participation in the study
Exclusion criteria
* History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL * Average screening blood pressure \>140/90 mmHg * History of cardiovascular disease * Pregnant, planning to become pregnant, or breastfeeding * Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Epinephrine Levels | 90 minute interval following initiation of insulin infusion | This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Glucose | 90 minute interval following initiation of insulin infusion | This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 6.3 |
| Fasting blood glucose | 86 mg/dL STANDARD_DEVIATION 4.7 |
| 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 | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Peak Epinephrine Levels
This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure
Time frame: 90 minute interval following initiation of insulin infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Peak Epinephrine Levels | 609 pg/mL | Standard Deviation 280 |
Secondary
CGM Glucose
This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure
Time frame: 90 minute interval following initiation of insulin infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | CGM Glucose | 56 mg/dL | Standard Deviation 3.9 |