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NCT04472962

The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.

Completed NA Last updated 15 February 2021
What this trial tests

NA trial testing Pre-exercise meal in Type 1 Diabetes in 14 participants. Completed in 30 January 2021.

Timeline
14 August 2020
Primary endpoint
30 January 2021
30 January 2021

Quick facts

Lead sponsorSteno Diabetes Center Copenhagen
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeprevention
Enrollment14
Start date14 August 2020
Primary completion30 January 2021
Estimated completion30 January 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Steno Diabetes Center Copenhagen — full company profile →

Who can join

Adults 18 to 70, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. The study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 57<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes.
    · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
  2. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy.
    McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, et al · · 2023 · cited 5× · PMID 36482870 · DOI 10.1111/dom.14938

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other Steno Diabetes Center Copenhagen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04472962.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing