Status:
COMPLETED
Hypoglycemia and Autonomic Nervous System Function- B2
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypoglycemia
Type2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.
Detailed Description
Participants are admitted for two days and two nights to an inpatient clinical research center for performance of study procedures. On Day 1, two hyperinsulinemic hypoglycemic (50 mg/dl) clamps are pe...
Eligibility Criteria
Inclusion
- Males and females age 18 to 55 years
- Type 2 Diabetes Mellitus controlled by diet, exercise and non-insulin glycemic control agents (metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors, alpha-glucosidase inhibitors or glucagon-like peptide-1 receptor agonist) or basal insulin at doses less than or equal to 0.3 units/ kg per day.
Exclusion
- Hemoglobin A1c \> 9% for type 2 diabetes
- Recurrent hypoglycemic episodes within the past month
- BMI \< 25 or \> 42 (Type 2 diabetes only)
- Pregnancy
- Lactation
- Clinically significant coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include congestive heart failure, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
- Current major depressive illness
- In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
- Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
- Blood pressure \> 160/100 mmHg (applies to participants with T2 diabetes)
- Creatinine \> 1.5 mg/dL
- Serum potassium \>5.2 mmol/L
- Estimated GFR \< 50 mL/min
- Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
- Use of beta-blockers or mineralocorticoid receptor antagonists
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03422471
Start Date
September 25 2017
End Date
November 25 2025
Last Update
January 2 2026
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115