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

This study is currently recruiting participants.
Verified January 2012 by Yale University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Robert Sherwin, Yale University
ClinicalTrials.gov Identifier:
NCT01194479
First received: September 1, 2010
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Drug: Formoterol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Formoterol
    Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
    Other Name: Foradil Aerolizer
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194479

Contacts
Contact: Renata Belfort de Aguiar, MD 203-785-6222 glucose.studies@yale.edu
Contact: Sarita Naik, MD 203-785-6222 glucose.studies@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Renata Belfort de Aguiar, MD     203-785-6222     glucose.studies@yale.edu    
Contact: Sarita Naik, MD     203-785-6222     glucose.studies@yale.edu    
Sub-Investigator: Renata Belfort de Aguiar, MD            
Sub-Investigator: Sarita Naik, MD            
Sub-Investigator: Barbara Szepietowska, M.D.            
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Robert Sherwin, Chief of Endocrinology, Yale University
ClinicalTrials.gov Identifier: NCT01194479     History of Changes
Other Study ID Numbers: HIC1005006832, R37-20495
Study First Received: September 1, 2010
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
type 1 diabetes
hypoglycemia
formoterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013