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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
Sponsor:
Information provided by (Responsible Party):
Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypoglycaemia Other: low amount of carbohydrates Other: high amount of carbohydrates Other: Rapid-acting carbohydrates Not Applicable

Detailed Description:
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.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: low amount of carbohydrates
2 x 10 g carbohydrates (muesli bars)
 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma glucose [ Time Frame: 6 hours ]

Eligibility Criteria
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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
Criteria

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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Contacts and Locations
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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): NCT02057848


Locations
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Germany
Diabeteszentrum
Bad Lauterberg, Germany, 37431
Sponsors and Collaborators
Michael A. Nauck
Investigators
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Principal Investigator: Michael A. Nauck, Prof. Dr. Diabeteszentrum
More Information
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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
Keywords provided by Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz:
carbohydrate, hypoglycemia
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases