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

NCT ID: NCT02057848

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Hypoglycaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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low amount of carbohydrates

2 x 10 g carbohydrates (muesli bars)

Group Type ACTIVE_COMPARATOR

low amount of carbohydrates

Intervention Type 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

2 x 20 g carbohydrates (muesli bars)

Group Type ACTIVE_COMPARATOR

high amount of carbohydrates

Intervention Type 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

30 g rapidly absorbable carboh. + 20 g muesli bar

Group Type OTHER

Rapid-acting carbohydrates

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael A. Nauck

OTHER

Sponsor Role lead

Responsible Party

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Michael A. Nauck

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael A. Nauck, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Diabeteszentrum

Locations

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Diabeteszentrum

Bad Lauterberg im Harz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-000561-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DZBL-2014-1

Identifier Type: -

Identifier Source: org_study_id

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