Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.

Type 1 Diabetes Clinical Trial

Official title:

The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01194479
• Other study ID #: HIC1005006832
• Secondary ID: R37-20495
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2010
• Last updated: June 27, 2013
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: June 2013
• Source: Yale University
• Contact: Renata Belfort de Aguiar, MD
• Phone: 203-785-6222
• Email: glucose.studies[@]yale.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Drug:
• Formoterol
Formoterol inhaler, 12mcg capsules, 4 capsules for one administration

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hormone Levels	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.	120 minutes	No
Secondary	Blood glucose levels	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.	5 minutes	Yes