Propranolol in Treating Hypoglycemia Unawareness

• Status: Terminated
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

Summary

Impaired awareness of hypoglycemia is common in type 1 diabetes (T1DM) patients. Impaired hypoglycemia awareness increases severe hypoglycemia risk by six-fold. Severe hypoglycemia compromises quality of life and can potentially cause death. The long-term goal of this pilot study is to lead to the development of novel therapeutic approaches to improve hypoglycemia awareness and thus prevent severe hypoglycemia development in T1DM population with impaired awareness of hypoglycemia.

It is hypothesized that propranolol will improve hypoglycemia recognition in T1DM. The specific aims of the study are to determine whether propranolol treatment improves subjects' recognition of hypoglycemic episodes, and improves hypoglycemic awareness scores; whether propranolol favorably increases hypoglycemia blood glucose nadir, decreases onset-to-treatment/recovery time (i.e. hypoglycemia duration), and reduces hypoglycemia/severe hypoglycemia frequency; and, whether propranolol reduces fear of hypoglycemia and improves overall blood glucose control.

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

Details

• Lead Sponsor: Anu Sharma; Yu Kuei (Alex) Lin
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• Subjects with Type 1 diabetes mellitus for more than 5 years with impaired awareness of hypoglycemia

• Age between 21 to 59 years old

• Hemoglobin A1c ≤ 9%; most recent value within 3 months

• No beta-blocker use history in the last 6 months

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

Exclusion Criteria:

• History of coronary, cerebral or peripheral vascular disease

• History of cardiac conduction abnormality or heart failure

• History of advanced liver disease

• Active malignancy

• Major Central or Peripheral Nervous System disease

• History of human immunodeficiency virus infection

• Contraindication to beta-blockers, including hypersensitivity to beta-blocker and bronchospastic disease

• Female in pregnancy or not able to practice effective contraception during the study period

• Concomitant acetaminophen use

• Currently utilizing unblinded real-time continuous glucose monitoring

• Advanced diabetic microvascular complications including retinopathy, neuropathy and nephropathy

• Inability to understand or cooperate with study procedure, including performing glucometer glucose assessment a minimum of four times a day, carrying glucose tablets and following standardized hypoglycemia treatment, completing hypoglycemia diary, wearing continuous glucose monitoring, and using a single glucometer

• Recent or current use or involvement in clinical studies of other therapies (e.g. opioid antagonist, SSRI, behavioral modification, relaxation of glycemic control) that may improve hypoglycemia awareness or prevent impaired hypoglycemia awareness development