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Carvedilol in Treating Hypoglycemia Unawareness

NCT03538015 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-11-25

Study results available
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Summary

Type 1 diabetes mellitus (T1DM) can lead to cardiovascular, renal and neurological complications if left poorly-controlled over prolonged periods of time. However, lowering glycemic goals for diabetic patients increases their risk for hypoglycemia exposure. Hypoglycemia is associated with symptoms such as heart palpitations, fatigue, shakiness, anxiety, confusion, and blurred vision. Recurrent hypoglycemia leads to impairment of the body's autonomic and symptomatic responses to this condition, and can result in loss of awareness in the patient of the hypoglycemic state. Repeated incidences of hypoglycemia from loss of this awareness can result in even more hypoglycemic episodes and more severe outcomes, such as loss of consciousness, accidents, hospitalization and even death if left untreated.

The aim of this study is to investigate whether adrenergic blockade through the use of low-dose carvedilol treatment can improve hypoglycemia awareness and the counterregulatory hormone responses to hypoglycemia in T1DM patients with impaired awareness of hypoglycemia.

Conditions

  • Hypoglycemia Unawareness

Interventions

DRUG

Carvedilol 3.125 mg

Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period

DRUG

Carvedilol 2.5 mg

Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period

DRUG

Placebo capsule

Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period

Sponsors & Collaborators

  • Owen Chan, PhD

    lead OTHER

Principal Investigators

  • Owen Chan, Ph.D. · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-08-10
Completion
2020-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538015 on ClinicalTrials.gov