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NCT04228822
Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
NA trial testing Low carbohydrate diet in Type 1 Diabetes in 8 participants. Completed in 28 February 2022.
28 February 2022
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 8 |
| Start date | 10 November 2020 |
| Primary completion | 28 February 2022 |
| Estimated completion | 28 February 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low carbohydrate diet
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Washington University School of Medicine
Who can join
Adults 5 to 11, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04228822
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Low carbohydrate diet
Trials testing the same drug.
- NCT05872711 — Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes · NA · unknown
- NCT05094505 — Isolated and Combined Effect of a Low Carbohydrate Diet and Exercise in Hypoxia in Patients With Type 2 Diabetes · NA · completed
- NCT04614168 — Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes · NA · completed
- NCT04213300 — Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes · completed
- NCT03880162 — Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes · NA · completed
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 Washington University School of Medicine trials
Trials by the same sponsor.
- NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
- NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
- NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
- NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
- NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
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 NCT04228822 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 9 March 2022
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/NCT04228822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing