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Trial Outcomes & Findings for Hypoglycemia and Autonomic Nervous System Function (NCT NCT01816893)

NCT ID: NCT01816893

Last Updated: 2018-04-02

Results Overview

The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 \[assessed 16 hours after the clamp\] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 \[baseline assessment on the day prior to the clamp\]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

16 hours after euglycemic and hypoglycemic clamps as compared to baseline

Results posted on

2018-04-02

Participant Flow

Participant milestones

Participant milestones
Measure
Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp
1. Participant undergoes a euglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a hypoglycemic hyperinsulinemic clamp
Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp
1. Participant undergoes a hypoglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a euglycemic hyperinsulinemic clamp
Euglycemic Clamp/ Hypoglycemic Clamp
STARTED
11
11
Euglycemic Clamp/ Hypoglycemic Clamp
COMPLETED
11
11
Euglycemic Clamp/ Hypoglycemic Clamp
NOT COMPLETED
0
0
Washout Period
STARTED
11
11
Washout Period
COMPLETED
9
11
Washout Period
NOT COMPLETED
2
0
Hypoglycemic Clamp/ Euglycemic Clamp
STARTED
9
11
Hypoglycemic Clamp/ Euglycemic Clamp
COMPLETED
9
11
Hypoglycemic Clamp/ Euglycemic Clamp
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp
1. Participant undergoes a euglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a hypoglycemic hyperinsulinemic clamp
Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp
1. Participant undergoes a hypoglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a euglycemic hyperinsulinemic clamp
Washout Period
Withdrawal by Subject
2
0

Baseline Characteristics

Hypoglycemia and Autonomic Nervous System Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp
n=11 Participants
1. Participant undergoes a euglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a hypoglycemic hyperinsulinemic clamp
Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp
n=11 Participants
1. Participant undergoes a hypoglycemic hyperinsulinemic clamp 2. Participant undergoes a 1-3 month washout period 3. Participant undergoes a euglycemic hyperinsulinemic clamp
Total
n=22 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=5 Participants
11 Participants
n=7 Participants
22 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
28 years
STANDARD_DEVIATION 6 • n=5 Participants
29 years
STANDARD_DEVIATION 8 • n=7 Participants
28 years
STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
9 Participants
n=7 Participants
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
11 Participants
n=5 Participants
11 Participants
n=7 Participants
22 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline

Population: 20 subjects completed both arms, but only 18 had the change in BRS outcome for both arms.

The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 \[assessed 16 hours after the clamp\] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 \[baseline assessment on the day prior to the clamp\]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.

Outcome measures

Outcome measures
Measure
Euglycemic Clamp
n=18 Participants
participant undergoes a euglycemic hyperinsulinemic clamp Euglycemia
Hypoglycemic Clamp
n=18 Participants
participant undergoes a hypoglycemic hyperinsulinemic clamp Hypoglycemia
Change in Baroreflex Sensitivity
2.3 ms/mmHg
Standard Deviation 6.3
-1.6 ms/mmHg
Standard Deviation 4.3

SECONDARY outcome

Timeframe: 16 hours after euglycemic and hypoglycemic clamps

Population: 20 subjects completed both arms, but only 5 had the muscle sympathetic nerve activity outcome for both arms.

Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.

Outcome measures

Outcome measures
Measure
Euglycemic Clamp
n=5 Participants
participant undergoes a euglycemic hyperinsulinemic clamp Euglycemia
Hypoglycemic Clamp
n=5 Participants
participant undergoes a hypoglycemic hyperinsulinemic clamp Hypoglycemia
Muscle Sympathetic Nerve Activity
With Nitroprusside
53.4 bursts/ minute
Standard Deviation 3.7
40.1 bursts/ minute
Standard Deviation 2.7
Muscle Sympathetic Nerve Activity
At rest
33.64 bursts/ minute
Standard Deviation 3.3
26.4 bursts/ minute
Standard Deviation 4.8

SECONDARY outcome

Timeframe: 16 hours after euglycemic and hypoglycemic clamps

Population: Of the 22 subjects who started the protocol, 20 completed both arms.

Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.

Outcome measures

Outcome measures
Measure
Euglycemic Clamp
n=20 Participants
participant undergoes a euglycemic hyperinsulinemic clamp Euglycemia
Hypoglycemic Clamp
n=20 Participants
participant undergoes a hypoglycemic hyperinsulinemic clamp Hypoglycemia
Catecholamine Response to Lower-body Negative Pressure
3.0 nmol/L
Standard Deviation 0.3
2.0 nmol/L
Standard Deviation 0.2

Adverse Events

Euglycemic Clamp

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hypoglycemic Clamp

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gail Kurr Adler

Brigham and Women's Hospital

Phone: (617) 732-8742

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place