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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.
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
Randomization:
Children will be randomly allocated into two groups of 25.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.
methods:
15.Both children and investigators will be blinded to CGMS results. 16.During the 3 day CGMS recording, the children's parents will be asked to monitor SBGM once during the night (in the intensive arm, following the exercise day).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Physical activity | Behavioral | |||
| Control- regular physical activity | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | 0,3 monthes | |
| fructosamine | 0,3 monthes |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition & BMR | 0,3 monthes | |
| Self esteem & QOL questionnaires | o, 3 monthes | |
| 3 days CGMS & SBGM profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ravital Nimri, MD | Contact | 972-39253778 | direct | ravitaln@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Ravital Nimri, MD | Rabin Medical Center | Principal Investigator |
| Moshe Phillip, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schnider children's medical center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 0,3 monthes |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |