Hypoglycemia and Autonomic Nervous System Function- B2

NCT03422471 | Completed DMC

• 5 other identifiers: 2004P001233-B2R01HL111465K24HL103845UL1TR001102T32HL007609
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.

Conditions

Hypoglycemia; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Modified Oxford Method Assessment of Baroreflex Function

  Change in baroreflex sensitivity between the first assessment (pre-AM clamp on Day 1) and the final assessment (AM of Day 2, about 16 hours after the PM clamp)

  Time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps

Study Arms (1)

Hypoglycemia

EXPERIMENTAL

Participants are exposed to two 90 minute episodes of hypoglycemia (50 mg/dl) through a hyperinsulinemic hypoglycemic clamp. Baroreflex sensitivity will be assessed before, during, and 16 hours after the hypoglycemia.

Other: Hyperinsulinemic Hypoglycemic Clamp

Interventions

Hyperinsulinemic Hypoglycemic Clamp OTHER

Participants will receive two 90 minute sessions of hypoglycemia. Baroreflex sensitivity will be assessed before, after, and during the sessions.

Hypoglycemia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Haas AV, Koefoed A, Easly RM, Celli J, Heydarpour M, Bonyhay I, Freeman R, Adler GK. Effect of hypoglycemia on baroreflex sensitivity in individuals with type 2 diabetes: implications for autonomic control of cardiovascular function in diabetes. Clin Auton Res. 2023 Dec;33(6):727-735. doi: 10.1007/s10286-023-00983-5. Epub 2023 Sep 21.

  PMID: 37733159 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gail Adler, MD/PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Roy Freeman, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: September 25, 2017
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared after completion of study and initial publications which we anticipate to be within 18 months of the final participant completing the study protocol.
• Access Criteria: Access to this information must be approved by the Partners IRB.

Locations

US (1)