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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02057848
Enrollment
37
Registered
2014-02-07
Start date
2011-07-31
Completion date
2014-02-28
Last updated
2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycaemia

Keywords

carbohydrate, hypoglycemia

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.

Interventions

OTHERlow 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

OTHERhigh 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

OTHERRapid-acting carbohydrates

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

Sponsors

Michael A. Nauck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frame
Plasma glucose6 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026