View Clinical Trial (Medical Research Study)
The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06520 |
| Conditions: |
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Type 1 Diabetes |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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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| NCT ID: |
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NCT01194479 |
| Primary Contact: |
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Principal Investigator
Robert Sherwin, MD
Yale School of Medicine
Renata Belfort de Aguiar, MD
Phone: 203-785-6222
Email: glucose.studies@yale.edu
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| Backup Contact: |
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Email: glucose.studies@yale.edu
Sarita Naik, MD
Phone: 203-785-6222
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| Location Contact: |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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