Back to resultsCarbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
Primary Purpose
Hypoglycaemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
low amount of carbohydrates
high amount of carbohydrates
Rapid-acting carbohydrates
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoglycaemia focused on measuring carbohydrate, hypoglycemia
Eligibility 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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Sites / Locations
- Diabeteszentrum
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
low amount of carbohydrates
high amount of carbohydrates
Rapid-acting carbohydrates
Arm Description
2 x 10 g carbohydrates (muesli bars)
2 x 20 g carbohydrates (muesli bars)
30 g rapidly absorbable carboh. + 20 g muesli bar
Outcomes
Primary Outcome Measures
Plasma glucose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02057848
Brief Title
Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael A. Nauck
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycaemia
Keywords
carbohydrate, hypoglycemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low amount of carbohydrates
Arm Type
Active Comparator
Arm Description
2 x 10 g carbohydrates (muesli bars)
Arm Title
high amount of carbohydrates
Arm Type
Active Comparator
Arm Description
2 x 20 g carbohydrates (muesli bars)
Arm Title
Rapid-acting carbohydrates
Arm Type
Other
Arm Description
30 g rapidly absorbable carboh. + 20 g muesli bar
Intervention Type
Other
Intervention Name(s)
low amount of carbohydrates
Intervention Description
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
Intervention Type
Other
Intervention Name(s)
high amount of carbohydrates
Intervention Description
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
Intervention Type
Other
Intervention Name(s)
Rapid-acting carbohydrates
Intervention Description
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
Primary Outcome Measure Information:
Title
Plasma glucose
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Nauck, Prof. Dr.
Organizational Affiliation
Diabeteszentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabeteszentrum
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
12. IPD Sharing Statement
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Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
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