Trial Outcomes & Findings for Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study (NCT NCT03839511)

Last Updated: 2021-08-19

Results Overview

This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure

Recruitment status

COMPLETED

Target enrollment

4 participants

Primary outcome timeframe

90 minute interval following initiation of insulin infusion

Results posted on

2021-08-19

Participant milestones
Measure	Intervention Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study

Baseline characteristics by cohort
Measure	Intervention n=4 Participants Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
Age, Continuous	32 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 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	3 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
Fasting blood glucose	86 mg/dL STANDARD_DEVIATION 4.7 • n=5 Participants

Timeframe: 90 minute interval following initiation of insulin infusion

This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure

Outcome measures
Measure	Intervention n=4 Participants Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
Peak Epinephrine Levels	609 pg/mL Standard Deviation 280

Timeframe: 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

Outcome measures
Measure	Intervention n=4 Participants Participants will undergo a hyperinsulinemic-hypoglycemic clamp procedure
CGM Glucose	56 mg/dL Standard Deviation 3.9

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Pennington Biomedical Research Center

Phone: 2257630278