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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000561-46 | EudraCT Number |
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Backgrounds/Aims: It was the aim to prospectively study the optimum regime of "preventive" carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity.
Research design and methods: 24 patients with type 1 diabetes participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m., either administering 2 x 10 g or 2 x 20 g carbohydrates (muesli bars) before starting and at 30 min (during the hike). Plasma glucose was determined with a laboratory method and additional carbohydrates needed to treat hypoglycaemia between 2 and 8 p.m. were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low amount of carbohydrates | Active Comparator | 2 x 10 g carbohydrates (muesli bars) |
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| high amount of carbohydrates | Active Comparator | 2 x 20 g carbohydrates (muesli bars) |
|
| Rapid-acting carbohydrates | Other | 30 g rapidly absorbable carboh. + 20 g muesli bar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low amount of carbohydrates | Other | different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | 6 hours |
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Inclusion Criteria:
Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration > 1 year
Exclusion Criteria:
General bad health status, Malignant diseases, Systemic glucocorticoid treatment, Coronary heart disease, Uncontrolled arterial hypertension, Acute infection diseases, Diseases of liver or kidney with significant organ malfunction, Abuse of alcohol or other drugs, Participation in another trial in the last 3 months
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Nauck, Prof. Dr. | Diabeteszentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabeteszentrum | Bad Lauterberg im Harz | 37431 | Germany |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| high amount of carbohydrates | Other | different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes |
|
| Rapid-acting carbohydrates | Other | different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes |
|