Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes

• ClinicalTrials.gov Identifier: NCT02057848
• Recruitment Status: Completed
• First Posted: February 7, 2014
• Last Update Posted: February 7, 2014
• Sponsor: Michael A. Nauck
• Information provided by (Responsible Party): Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz

Tracking Information

• First Submitted Date: February 5, 2014
• First Posted Date: February 7, 2014
• Last Update Posted Date: February 7, 2014
• Study Start Date: July 2011
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 6, 2014): Plasma glucose [ Time Frame: 6 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Hypoglycaemia

Intervention

• 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
• 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
• 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

Study Arms

• Active Comparator: low amount of carbohydrates
  2 x 10 g carbohydrates (muesli bars)
  Intervention: Other: low amount of carbohydrates
• Active Comparator: high amount of carbohydrates
  2 x 20 g carbohydrates (muesli bars)
  Intervention: Other: high amount of carbohydrates
• Rapid-acting carbohydrates
  30 g rapidly absorbable carboh. + 20 g muesli bar
  Intervention: Other: Rapid-acting carbohydrates

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2014): 37
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

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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Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02057848
• Other Study ID Numbers: DZBL-2014-1; 2014-000561-46 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
• Study Sponsor: Michael A. Nauck
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael A. Nauck, Prof. Dr.; Diabeteszentrum

• PRS Account: Diabeteszentrum Bad Lauterberg im Harz
• Verification Date: February 2014