Type 1 Diabetes Clinical Trial
Official title:
The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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