Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 1, 2010 | ||||||||
| Last Updated Date | January 25, 2012 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01194479 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes. | ||||||||
| Official Title ICMJE | The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | 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 Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Type 1 Diabetes | ||||||||
| Intervention ICMJE | Drug: Formoterol
Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
Other Name: Foradil Aerolizer |
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01194479 | ||||||||
| Other Study ID Numbers ICMJE | HIC1005006832, R37-20495 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Robert Sherwin, Yale University | ||||||||
| Study Sponsor ICMJE | Yale University | ||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Yale University | ||||||||
| Verification Date | January 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||