Hypoglycemia and Autonomic Nervous System Function- B2

Type2 Diabetes Clinical Trial

— HypoANS-B2  

Official title:

Hypoglycemia and Autonomic Nervous System Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422471
• Other study ID #: 2004P001233-B2
• Secondary ID: R01HL111465K24HL
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: October 28, 2024

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 performed - an AM clamp from about 9 to 11 am and a PM clamp from about 1 to 3 pm.. Modified Oxford procedures are performed in duplicate at five time points -- before the AM clamp, during the AM clamp, before the PM clamp, during the PM clamp, and the morning of Day 2 (about 16 hrs after completion of the the PM clamp). The Modified Oxford procedure involves the sequential intravenous administration of nitroprusside and phenylephrine with assessment of blood pressure and heart rate by finapress. Baroreflex sensitivity is the relationship of changes in heart rate to changes in blood pressure. .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: October 28, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hypoglycemia
• Type2 Diabetes

Intervention

Other:
• Hyperinsulinemic Hypoglycemic Clamp
Participants will receive two 90 minute sessions of hypoglycemia. Baroreflex sensitivity will be assessed before, after, and during the sessions.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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