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Completed

NCT Number: NCT02057848

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

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.

Completed

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Key information

Conditions

Hypoglycaemia Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabeteszentrum

Bad Lauterberg im Harz, 37431, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

low amount of carbohydrates

Other

different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes

high amount of carbohydrates

Other

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

Other

different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes

Primary outcomes

  1. Plasma glucose

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Michael A. Nauck

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2014
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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