Hypoglycemia and Autonomic Nervous System Function

Not Applicable

Completed

• Conditions: Hypoglycemia
• Interventions: Other: Euglycemic hyperinsulinemic clamp; Other: Hypoglycemic hyperinsulinemic clamp

• Registration Number: NCT01816893
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-08
• Primary Completion: 2007-11-06
• Study Completion: 2007-11-06
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Results First Submitted: 2018-01-30
• Results First Submitted QC: 2018-01-30
• Status Verified: 2018-03
• Results First Posted: 2018-03-06
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Euglycemic hyperinsulinemic clamp	Euglycemic hyperinsulinemic clamp	participant undergoes a euglycemic hyperinsulinemic clamp
Hypoglycemic hyperinsulinemic clamp	Hypoglycemic hyperinsulinemic clamp	participant undergoes a hypoglycemic hyperinsulinemic clamp

Primary Outcome Measures

Name	Time	Method
Change in Baroreflex Sensitivity	16 hours after euglycemic and hypoglycemic clamps as compared to baseline	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.

Secondary Outcome Measures

Name	Time	Method
Muscle Sympathetic Nerve Activity	16 hours after euglycemic and hypoglycemic clamps	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.
Catecholamine Response to Lower-body Negative Pressure	16 hours after euglycemic and hypoglycemic clamps	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.

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States