Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 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:
NCT00109434
First received: April 27, 2005
Last updated: January 10, 2008
Last verified: September 2005
  Purpose

The main purpose of this study is to find out how often low blood sugar (hypoglycemia) happens during the night after exercise in the late afternoon. The study also will see if there are any factors that can predict if low blood sugar is going to develop. Blood samples will also be drawn to measure two hormones—glucagon and epinephrine (adrenaline)—to see how they are affected by exercise. Glucagon helps to raise the blood sugar when it is low. Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the blood sample, other substances in the blood may also be measured to see how they are affected by exercise.

A second purpose of the study is to find out whether exercise affects the accuracy of a continuous glucose sensor (CGMS made by Medtronic Minimed).

The study will also look at the accuracy of different home glucose meters.


Condition
Diabetes Mellitus, Type I

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effect of Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes; A Study Being Conducted by the Diabetes Research in Children Network

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hypoglycemia defined as <=70 mg/dL.

Secondary Outcome Measures:
  • Changes in epinephrine and glucagon levels.

Estimated Enrollment: 50
Study Start Date: June 2004
Estimated Study Completion Date: November 2004
Detailed Description:

Many children and adults with type 1 diabetes have a drop in the blood sugar during exercise. When someone has low blood sugar, the body tries to return the blood sugar to normal. Some studies show that after exercise, the blood sugar may drop later in the day or during the night. However, it is not known how often this happens. Also, not enough is known about how exercise affects blood sugar or the awareness of low blood sugar.

Some studies in adults have shown that exercise may affect the body's natural response to low blood sugar and exercise in the future.

For this study, each subject will have two in-patient hospital stays 1 to 4 weeks apart, each lasting about 24 hours: one with no exercise and one with a 75-minute exercise session in the late afternoon. (The order of the exercise and sedentary days will be determined at random.)

Prior to each hospital admission, each subject will keep a detailed diary of insulin use and hypoglycemia for one week.

On each of the two admissions, the insulin regimens and diet will be as similar as possible.

On each of the 2 admissions, the following will occur:

  • A CGMS sensor will be inserted and calibrated.
  • An intravenous catheter for the collection of blood samples will be inserted.
  • Blood sugar measurements will be made with an Ultra, BD Logic, and Freestyle meter every half hour beginning at 10:00 p.m. through 6:00 a.m.
  • Blood samples for glucagon, epinephrine, and glucose will be collected hourly from 10:00 p.m. to 6:00 a.m.

On the exercise day only,

  • In the morning, the subject will run on the treadmill for about 5 minutes to determine the settings needed to achieve a heart rate of 140.
  • Exercise will begin at approximately 4:00PM and will consist of 15 minutes on a treadmill at a heart rate of approximately 140 followed by a 5-minute rest period. This cycle will be repeated 3 more times for a total of four 15-minute exercise periods with 5-minute rest periods in between (75 minutes total). A heart rate monitor will be worn throughout the time of exercise to ascertain the effort put forth.
  • BG (blood glucose) measurements will be made using the Ultra, BD Logic, and Freestyle meters (1) prior to starting the exercise, (2) during each of the 3 rest periods, (3) immediately following the exercise session, and (4) at 15 minute intervals for one hour following the completion of the exercise. Blood samples will be collected for the central lab at the times of sampling for glucagon and epinephrine.
  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 for at least 18 months
  • HbA1c <10.0% as measured by the DCA2000.
  • Age 10.0 to <18.0 years
  • Weight >36.0 kg
  • BMI (body mass index) >5th and <95th percentiles for age/gender
  • Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study
  • Insulin regimen involves either use of an insulin pump or Lantus (with short-acting insulin)
  • NPH or Lente, if part of the insulin regimen, is given only in the morning before breakfast
  • Normal hematocrit (within normal limits of local laboratory)
  • Normal thyroid function (measured within the previous year)
  • Parent/guardian and subject understand the study protocol and agree to comply with it
  • Informed Consent Form signed by the parent/guardian and Child Assent Form signed

Exclusion Criteria:

  • Insulin regimen includes Ultralente/Lente or NPH at times other than the morning before breakfast
  • 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 CRC admission (if used in the 48 hours prior to the scheduled second admission, the admission will be deferred)
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to CRC admission (if a severe episode occurs within 2 weeks prior to the scheduled second admission, the admission will be deferred)
  • Active infection (if at the time of the planned second admission an infection is present, the admission will be deferred)
  • Anticipating a significant change in exercise regimen between admissions (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: NCT00109434

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
Denver, Colorado, United States, 80262
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
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:
Eva Tsalikian, Roy Beck, Peter Chase, Tim Wysocki, Bruce Buckingham, Stuart Weinzimer, Nelly Mauras, Katrina Ruedy, Craig Kollman, Dongyuan Xing, Katrina Ruedy, William Tamborlane and the Diabetes Research in Children Network (DirecNet) Study Group: Impact of Exercise on Overnight Glycemic Control in Children with Type 1 Diabetes (T1DM). Diabetes 2005; 54(Suppl 1):A64.

ClinicalTrials.gov Identifier: NCT00109434     History of Changes
Other Study ID Numbers: DirecNet 005, HD41890
Study First Received: April 27, 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
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014