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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Type 1 Diabetics

The active group were participants with type 1 diabetes.

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

Formoterol inhaler, 12mcg capsules, 4 capsules for one administration

Placebo

Intervention Type OTHER

Participants in both arms received placebo on 1 of the 2 visits.

Healthy Volunteers

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

Group Type OTHER

Formoterol

Intervention Type DRUG

Formoterol inhaler, 12mcg capsules, 4 capsules for one administration

Placebo

Intervention Type OTHER

Participants in both arms received placebo on 1 of the 2 visits.

Interventions

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Formoterol

Formoterol inhaler, 12mcg capsules, 4 capsules for one administration

Intervention Type DRUG

Placebo

Participants in both arms received placebo on 1 of the 2 visits.

Intervention Type OTHER

Other Intervention Names

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Foradil Aerolizer

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No