Hypoglycemia and Autonomic Nervous System Function (HypoANS)

Mass General Brigham

Status: Completed

Conditions: Hypoglycemia

Treatments: Other: Euglycemic hyperinsulinemic clamp; Other: Hypoglycemic hyperinsulinemic clamp

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01816893

M01RR002635 (U.S. NIH Grant/Contract)

2004P001233

R01DK063296 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy volunteers
• Males and females age 18 to 50 years

Exclusion Criteria

• Pregnancy
• Lactation
• Subjects who smoke or are on other forms of nicotine will be excluded
• Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
• Current major depressive illness
• Any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
• Use of medications other than thyroxine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Euglycemic hyperinsulinemic clamp

Sham Comparator group

Description:

participant undergoes a euglycemic hyperinsulinemic clamp

Treatment:

Other: Euglycemic hyperinsulinemic clamp

Hypoglycemic hyperinsulinemic clamp

Active Comparator group

Description:

participant undergoes a hypoglycemic hyperinsulinemic clamp

Treatment:

Other: Hypoglycemic hyperinsulinemic clamp