Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT02057848 |
Recruitment Status :
Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoglycaemia | Other: low amount of carbohydrates Other: high amount of carbohydrates Other: Rapid-acting carbohydrates | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Prospective, Randomized Trial Testing Different Regimens of Carbohydrate Administration to Prevent Hypoglycaemia During a Standardized Bout of Moderate Physical Activity in Patients With Type 1 Diabetes |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: low amount of carbohydrates
2 x 10 g carbohydrates (muesli bars)
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Other: low amount of carbohydrates
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes |
Active Comparator: high amount of carbohydrates
2 x 20 g carbohydrates (muesli bars)
|
Other: high amount of carbohydrates
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
30 g rapidly absorbable carboh. + 20 g muesli bar
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Other: Rapid-acting carbohydrates
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes |
- Plasma glucose [ Time Frame: 6 hours ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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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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): NCT02057848
Germany | |
Diabeteszentrum | |
Bad Lauterberg, Germany, 37431 |
Principal Investigator: | Michael A. Nauck, Prof. Dr. | Diabeteszentrum |
Responsible Party: | Michael A. Nauck, Prof. Dr. med., Diabeteszentrum Bad Lauterberg im Harz |
ClinicalTrials.gov Identifier: | NCT02057848 |
Other Study ID Numbers: |
DZBL-2014-1 2014-000561-46 ( EudraCT Number ) |
First Posted: | February 7, 2014 Key Record Dates |
Last Update Posted: | February 7, 2014 |
Last Verified: | February 2014 |
carbohydrate, hypoglycemia |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |