Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2010 |
| End Date: | August 2014 |
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.
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.
Note: Below is the original detailed description submitted in 2010. The recruitment for this
study was stopped at 7 subjects in each study arm. The study design and outcome measures did
not change for this study. See below for further details.
Original: 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.
study was stopped at 7 subjects in each study arm. The study design and outcome measures did
not change for this study. See below for further details.
Original: 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.
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
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