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

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ClinicalTrials.gov Identifier: NCT00491465
Recruitment Status : Unknown
Verified June 2007 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
Sponsor:
Information provided by:
Rabin Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Intensive Physical activity Behavioral: Control- regular physical activity Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2007 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : July 2007
Estimated Study Completion Date : July 2009

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U.S. FDA Resources




Primary Outcome Measures :
  1. HbA1C [ Time Frame: 0,3 monthes ]
  2. fructosamine [ Time Frame: 0,3 monthes ]

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


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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00491465


Contacts
Contact: Ravital Nimri, MD 972-39253778 ext direct ravitaln@clalit.org.il

Locations
Israel
Schnider children's medical center Not yet recruiting
Petach-Tikva, Israel
Principal Investigator: Ravital Nimri, MD         
Principal Investigator: Moshe Phillip, Prof.         
Sub-Investigator: Rachel Frumkin, MD         
Sub-Investigator: Neomi Weintrob, MD         
Sub-Investigator: Shlomit Shalitin, MD         
Sub-Investigator: Nesia Nagelberg, MA         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ravital Nimri, MD Rabin Medical Center
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center

ClinicalTrials.gov Identifier: NCT00491465     History of Changes
Other Study ID Numbers: rmc074301ctil
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007

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