Randomized,Controlled,Open,Cross-Over Intervention Study for Evaluating the Role of Physical Activity in the Treatment of Children With Type 1 Diabetes.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 2,007
- Locations
- 2
- Primary Endpoint
- HbA1C
Study Overview
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.
Detailed Description
Randomized, controlled, open, comparative, cross-over, intervention study in 50 children with type 1 diabetes.
objectives:
Primary objective To evaluate the efficacy and safety of physical activity for metabolic control in children with type I diabetes.
Secondary objectives
- To characterize the severity and pattern of occurrence of hypo and hyperglycemic episodes during and after exercise program in type I diabetic children.
- To evaluate changes in insulin sensitivity during and after periods of exercise in type I diabetic children.
- To evaluate the short term effect of exercise on BMI and body composition in type I diabetic children.
- To evaluate the short term effect of exercise on lipid profile in type I diabetic children.
- To evaluate differences in self esteem and quality of life between exercising and non exercising type I diabetic children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type I diabetic children
- •Tanner stage II-IV
- •Patients of the Schneider's national institute of childhood diabetes. Duration of diabetes
- •more than one year.
- •HbA1C between 8 and 12 at time
- •Mandatory 4 daily self blood glucose measurements and daily recording of adverse events.
- •A signed informed consent of the parents and child.
Exclusion Criteria
- •Additional chronic significant disease such as cardiac, liver, renal disease .
- •Children who exercise regularly more than 180 min per week.
- •Cardiac symptoms: history of chest pain , syncope , palpitations or dyspnea during exercise.
- •Eating disorders.
- •Participation in a study during the past month.
Outcomes
Primary Outcomes
HbA1C
Time Frame: 0,3 monthes
fructosamine
Time Frame: 0,3 monthes
Secondary Outcomes
- Body composition & BMR(0,3 monthes)
- Self esteem & QOL questionnaires(o, 3 monthes)
- 3 days CGMS & SBGM profile(0,3 monthes)