Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00974051
First received: September 9, 2009
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).


Condition Intervention
Type 1 Diabetes
Drug: Terbutaline
Other: 20% basal insulin reduction
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Using Terbutaline or a Reduction in Basal Insulin Infusion as a Therapeutic Agent to Prevent Delayed Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Blood Glucose Nadir [ Time Frame: overnight hours ] [ Designated as safety issue: No ]
    BG nadir overnight after intervention


Secondary Outcome Measures:
  • Percent of Nighttime Glucose Levels <80 [ Time Frame: 9:00pm to 6:00am ] [ Designated as safety issue: No ]
  • Percent of Nighttime Glucose Levels <70 [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]
  • Percent of Nighttime Glucose Levels >250 mg/dl [ Time Frame: 10:00pm to 6:00am ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Subjects complete the same exercise routine, however no treatment is given at 9:00pm.
Other: Control
No treatment is given for the study. This arm is for comparison with the two intervention arms.
Other Name: No intervention
Experimental: Terbutaline
Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered.
Drug: Terbutaline
Oral (2.5mg) one time administration at 9:00pm
Other Name: β2-adrenergic agonist
Experimental: 20% Basal Insulin Reduction
All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours.
Other: 20% basal insulin reduction
Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
Other Name: 80% basal insulin

Detailed Description:

In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with type 1 diabetes for at least one year and on an insulin pump for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an HbA1c less than 10.0% and normal thyroid function. Subjects can not have had a severe hypoglycemic episode in the last three months, any other illness or treatment that may affect the wearing of a continuous glucose monitor or the completion of the study as determined by the investigator. Subjects may not use drugs containing pseudoephedrine within 48 hours of the study visits.

This study consists of three overnight visits at the Clinical Translational Research Center. Meals eaten during the study will be consistent for each of the three visits.

Subjects will participate in a standardized afternoon exercise session on a treadmill as has been done in previous Diabetes Research in Children Network studies. Exercise will begin at 4pm and must be completed by 6pm. Dinner will be eaten at the end of the exercise.

At 9pm, treatment will be given as determined by the randomization group the subject is assigned to. The treatment includes either an oral dose of 2.5mg Terbutaline, a 20% basal reduction for six hours or no treatment as the control. Blood glucose levels will be measured every 30 minutes until 6am.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Type 1 Diabetes and using daily insulin therapy for at least one year.
  • Age 10 to 17 years, inclusive.
  • HbA1c < 10.0%.
  • BMI 5-95th % for age and gender.
  • Stable Continuous Subcutaneous Insulin Infusion regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study.
  • Subject uses a downloadable insulin pump.
  • Normal thyroid function (measured within the previous year).
  • For females, subject not intending to become pregnant during the study.
  • No expectation that subject will be moving out of the area for the duration of the study.
  • Informed consent form signed and understood by the parent/guardian and Child Assent form signed/understood by subjects.

Exclusion Criteria:

  • The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  • A recent injury to body or limb, Addison's disease, muscular disorder or disease in the judgment of the investigator that will affect the completion of the exercise protocol.
  • Asthma which has been medically treated within the last year.
  • Medically diagnosed cardiac disease, hypertension, or autonomic dysfunction.
  • Use of pseudoephedrine 48 hours prior to the visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
  • Severe hypoglycemia resulting in seizure of loss of consciousness in the 3 months prior to a visit.
  • Active infection (if at the time of the scheduled visit and infection is present, the visit will be deferred).
  • Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport).
  • Treatment with systemic or inhaled corticosteroids in the last 6 months.
  • Current treatment with B-blockers or presenting with high blood pressure.
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver.
  • Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  • Known allergy to Terbutaline
  • Treatment with atenolol (Tenormin), carteolol (Cartrol), labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard), phenelzine (Nardil), propranolol (Inderal), sotalol (Betapace), theophylline (Theo-Dur), timolol (Blocadren), tranylcypromine (Parnate), other medications for asthma, heart disease or depression.
  • Treatment with ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine.
  • The presence of an irregular heart beat, increased heart rate glaucoma or an overactive thyroid gland.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974051

Locations
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Rosanna Fiallo-Scharer, MD University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00974051     History of Changes
Other Study ID Numbers: 07-0392
Study First Received: September 9, 2009
Results First Received: September 17, 2012
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Children
Exercise
Hypoglycemia

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

ClinicalTrials.gov processed this record on September 29, 2014