Trial Outcomes & Findings for The Autonomic Nervous System and the Metabolic Syndrome (NCT NCT00580957)

NCT ID: NCT00580957

Last Updated: 2016-08-05

Results Overview

Glucose infusion rate in mg/kg/min

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: Last 30 minutes of a two hour insulin clamp
• Results posted on: 2016-08-05

Participant Flow

Participant milestones

Measure	Blocked Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance	Intact Saline will be used instead of trimethaphan during insulin clamp Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
Overall Study STARTED	28	28
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Autonomic Nervous System and the Metabolic Syndrome

Baseline characteristics by cohort

Measure	Blocked Then Intact n=21 Participants Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance	Intact Then Blocked n=21 Participants Saline will be used instead of trimethaphan during insulin clamp Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance	Total n=42 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	21 Participants n=5 Participants	21 Participants n=7 Participants	42 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	44 years STANDARD_DEVIATION 6 • n=5 Participants	43 years STANDARD_DEVIATION 5 • n=7 Participants	43 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Last 30 minutes of a two hour insulin clamp

Glucose infusion rate in mg/kg/min

Outcome measures

Measure	Blocked n=21 Participants Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance	Intact n=21 Participants Saline will be used instead of trimethaphan during insulin clamp Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
Insulin Resistance	3.8 mg/kg/min Standard Error 0.3	3.1 mg/kg/min Standard Error 0.3

Adverse Events

Blocked

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intact

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

Italo Biaggioni, M.D. Professor of Medicine

Vanderbilt University

Phone: (615) 936-3420

Email: italo.biaggioni@vanderbilt.edu

Results disclosure agreements

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