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The Role of Physical Activity in the Treatment of Children With Type 1 Diabetes. (4301)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00491465
First received: June 25, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose
Randomized, controlled, open, comparative intervention study in two groups, each consisting of 25 children with type 1 diabetes that will undergo twelve weeks of exercise program (intensive arm) and twelve weeks of regular activity (non intensive arm) separated by four week of washout period. The study will be conducted in a crossover manner: one group starting with the intensive arm followed by the non intensive arm and vice versa. Blood glucose, HbA1C, Fructosamine, 3 days continuous glucose monitoring system (CGMS), total daily insulin dose, fasting lipid profile, body impedance and BMR will be measured. Self esteem and quality of life questionnaires will be filled.

Condition Intervention
Type 1 Diabetes
Behavioral: Intensive Physical activity
Behavioral: Control- regular physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized,Controlled,Open,Cross-Over Intervention Study for Evaluating the Role of Physical Activity in the Treatment of Children With Type 1 Diabetes.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • HbA1C [ Time Frame: 0,3 monthes ]
  • fructosamine [ Time Frame: 0,3 monthes ]

Secondary Outcome Measures:
  • Body composition & BMR [ Time Frame: 0,3 monthes ]
  • Self esteem & QOL questionnaires [ Time Frame: o, 3 monthes ]
  • 3 days CGMS & SBGM profile [ Time Frame: 0,3 monthes ]

Estimated Enrollment: 2007
Study Start Date: July 2007
Estimated Study Completion Date: July 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type I diabetic children
  2. Tanner stage II-IV
  3. Patients of the Schneider's national institute of childhood diabetes. Duration of diabetes
  4. more than one year.
  5. HbA1C between 8 and 12 at time 0.
  6. Mandatory 4 daily self blood glucose measurements and daily recording of adverse events.
  7. A signed informed consent of the parents and child.

Exclusion Criteria:

  1. Additional chronic significant disease such as cardiac, liver, renal disease .
  2. Children who exercise regularly more than 180 min per week.
  3. Cardiac symptoms: history of chest pain , syncope , palpitations or dyspnea during exercise.
  4. Eating disorders.
  5. Participation in a study during the past month.
  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: NCT00491465

Locations
Israel
Schnider children's medical center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ravital Nimri, MD Rabin Medical Center
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00491465     History of Changes
Other Study ID Numbers: rmc074301ctil 
Study First Received: June 25, 2007
Last Updated: June 25, 2007
Health Authority: Israel: Clalit Health Services

Keywords provided by Rabin Medical Center:
Type 1 Diabetes, physical activity, pediatric, metabolic control

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 December 05, 2016