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

Not Applicable

Completed

• Conditions: Hypoglycaemia
• Interventions: Other: Rapid-acting carbohydrates; Other: low amount of carbohydrates; Other: high amount of carbohydrates

• Registration Number: NCT02057848
• Lead Sponsor: Michael A. Nauck

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 Timeline

• Study Start: 2011-07
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rapid-acting carbohydrates	Rapid-acting carbohydrates	30 g rapidly absorbable carboh. + 20 g muesli bar
low amount of carbohydrates	low amount of carbohydrates	2 x 10 g carbohydrates (muesli bars)
high amount of carbohydrates	high amount of carbohydrates	2 x 20 g carbohydrates (muesli bars)

Primary Outcome Measures

Name	Time	Method
Plasma glucose	6 hours

Trial Locations

Locations (1)

Diabeteszentrum; 🇩🇪 Bad Lauterberg, Germany