Trial record 4 of 47 for:    diabetes | NICHD [Lead] | NIH

The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00147342
First received: September 2, 2005
Last updated: January 10, 2008
Last verified: December 2006
  Purpose

Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin pump, there is an opportunity to reduce the basal insulin rate during exercise. This study is being conducted to determine if decreasing the insulin that is received during exercise will reduce the risk of hypoglycemia. We hope to learn more about how the body responds to hypoglycemia and to hyperglycemia (high blood sugar) when it occurs.

As part of the study, children will have a visit on two different days. During each visit, children will exercise on a treadmill for about 60 minutes. During one of the visits, the children's basal rate will be continued during the exercise. During one visit, the basal insulin will be stopped. The blood sugar will be checked frequently during the exercise.


Condition
Diabetes Mellitus, Type I

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 55
Study Start Date: May 2005
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least 18 months (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
  • HbA1c <10.0% (The DCA2000 will be used to assess eligibility.)
  • Age 8.0 to <18.0 years
  • Weight >39.5 kg at reinfusion centers and >46.0 kg at discard centers
  • BMI >5th and <95th percentiles for age and gender
  • Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump.)
  • Insulin regimen involves use of an insulin pump
  • Normal thyroid function (measured within the previous year)

Exclusion Criteria:

  • A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
  • Asthma which has been medically treated within the last year
  • Current use of glucocorticoid medication (by any route of administration)
  • Current use of a beta blocker medication
  • Use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
  • Active infection (if at the time of the scheduled visit an 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)
  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: NCT00147342

Locations
United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Iowa
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Study Chair: William V Tamborlane, M.D. Department of Pediatrics, Yale University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00147342     History of Changes
Other Study ID Numbers: DirecNet 007, HD041890, HD041906, HD041918, HD041915, HD041908, HD041919
Study First Received: September 2, 2005
Last Updated: January 10, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
exercise
hypoglycemia
Diabetes Mellitus, Type I
glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014