Last reviewed · How we verify
NCT04472962
The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.
NA trial testing Pre-exercise meal in Type 1 Diabetes in 14 participants. Completed in 30 January 2021.
30 January 2021
Quick facts
| Lead sponsor | Steno Diabetes Center Copenhagen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 14 |
| Start date | 14 August 2020 |
| Primary completion | 30 January 2021 |
| Estimated completion | 30 January 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Pre-exercise meal
- Pre-exercise meal
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
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):
-
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 -
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:
- PubMed search for NCT04472962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes
Currently open trials in the same condition.
- NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
- NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
- NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
- NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Other Steno Diabetes Center Copenhagen trials
Trials by the same sponsor.
- NCT07485075 — Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical · NA · recruiting
- NCT07427251 — The Postprandial Hypo-Avoid Study · Phase 4 · not yet recruiting
- NCT06954090 — Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study · Phase 4 · enrolling by invitation
- NCT06832059 — Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in T · NA · recruiting
- NCT07377266 — The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of t · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04472962 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Steno Diabetes Center Copenhagen
- Last refreshed: 15 February 2021
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