New Haven, Connecticut 06520

  • Type 1 Diabetes

Purpose:

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.


Study summary:

15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study. If you agree to participate in this study, you will be asked to participate in a screening at Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.


Criteria:

Inclusion Criteria: - type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) - age 18-50 - BMI 18-30 Exclusion Criteria: - pregnancy - significant diabetes complications - liver disease, cirrhosis - cardiac disease - neurological disorder - autonomic neuropathy - kidney disease - lactose intolerance


NCT ID:

NCT01194479


Primary Contact:

Principal Investigator
Robert Sherwin, MD
Yale School of Medicine

Renata Belfort de Aguiar, MD
Phone: 203-785-6222
Email: glucose.studies@yale.edu


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States

Renata Belfort de Aguiar, MD
Phone: 203-785-6222
Email: glucose.studies@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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