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

Yale University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Placebo; Drug: Formoterol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01194479

HIC1005006832

R37-20495 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Type 1 Diabetics

Active Comparator group

Description:

The active group were participants with type 1 diabetes.

Treatment:

Drug: Formoterol

Other: Placebo

Healthy Volunteers

Other group

Description:

The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.

Treatment:

Drug: Formoterol

Other: Placebo