Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia|
- Hormone Levels [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]Glucagon and catecholamine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session.
- Blood glucose levels [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194479
|Contact: Renata Belfort de Aguiar, MDfirstname.lastname@example.org|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Renata Belfort de Aguiar, MD 203-785-6222 email@example.com|
|Sub-Investigator: Renata Belfort de Aguiar, MD|
|Sub-Investigator: Barbara Szepietowska, M.D.|
|Principal Investigator:||Robert Sherwin, MD||Yale School of Medicine|