Carvedilol in Treating Hypoglycemia Unawareness

• Status: Terminated
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Owen Chan, PhD
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• History of Type 1 diabetes mellitus for more than 5 years

• Age > 18 years

• Presence of impaired hypoglycemia awareness/unawareness

• Intensive insulin treatment as defined by multiple daily insulin injections (3 or more) or insulin pump therapy

• Negative pregnancy test

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

• Major medical disorders (including liver disease, cardiovascular disease, kidney disease, chronic obstructive pulmonary disease, asthma, active malignancy or HIV)

• Overt diabetes complications (neuropathy, nephropathy, retinopathy)

• Presence of anemia

• Current or recent use of beta-blocker therapy

• Use of diuretics

• Allergies or contraindications to beta-blockers or heparin

• Use of benzodiazepines

• Alcohol, drug or medication abuse

• Frequent use of acetaminophen