Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974051
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Terbutaline Other: 20% basal insulin reduction Other: Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Blood Glucose Nadir [ Time Frame: overnight hours ]
    BG nadir overnight after intervention

Secondary Outcome Measures :
  1. Percent of Nighttime Glucose Levels <80 [ Time Frame: 9:00pm to 6:00am ]
  2. Percent of Nighttime Glucose Levels <70 [ Time Frame: 10:00pm to 6:00am ]
  3. Percent of Nighttime Glucose Levels >250 mg/dl [ Time Frame: 10:00pm to 6:00am ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974051

Layout table for location information
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Layout table for investigator information
Principal Investigator: Rosanna Fiallo-Scharer, MD University of Colorado, Denver

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Colorado, Denver Identifier: NCT00974051     History of Changes
Other Study ID Numbers: 07-0392
First Posted: September 10, 2009    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013
Last Verified: August 2013

Keywords provided by University of Colorado, Denver:

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