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CompletedNCT02057848Updated Feb 7, 2014

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

An interventional study of low amount of carbohydrates and high amount of carbohydrates in Hypoglycaemia, sponsored by Michael A. Nauck. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-02-07.

Sponsored by Michael A. Nauck · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoglycaemia

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Keywords

  • carbohydrate, hypoglycemia
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 37 is above the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Michael A. Nauck is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration > 1 year

Exclusion criteria

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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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    low amount of carbohydrates

    2 x 10 g carbohydrates (muesli bars)

    Other: low amount of carbohydrates

  • Active comparator
    high amount of carbohydrates

    2 x 20 g carbohydrates (muesli bars)

    Other: high amount of carbohydrates

  • Other
    Rapid-acting carbohydrates

    30 g rapidly absorbable carboh. + 20 g muesli bar

    Other: Rapid-acting carbohydrates

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

06

What researchers measure

Primary outcomes

  1. Plasma glucose

    Time frame: 6 hours

07

Study locations

1 site
  • Diabeteszentrum
    Bad Lauterberg, 37431, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02057848
Lead sponsor
Michael A. Nauck
Responsible party
Michael A. Nauck (Prof. Dr. med., Diabeteszentrum Bad Lauterberg im Harz) — Sponsor-investigator
First posted
Feb 7, 2014
Start date
Jul 2011
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Feb 7, 2014

Study contacts

Michael A. Nauck, Prof. Dr.
principal investigator · Diabeteszentrum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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