Who is sponsoring NCT03862521?

NCT03862521 is sponsored by Nemours Children's Clinic.

What drugs are being tested in NCT03862521?

Interventions in NCT03862521: Low carbohydrate diet, Very low carbohydrate diet.

What condition does NCT03862521 study?

NCT03862521 studies Type 1 Diabetes Mellitus, Diet Modification, Child, Only.

Is NCT03862521 still recruiting?

NCT03862521 is currently completed. Last updated 25 May 2022.

Last reviewed 2022-05-25 · How we verify

NCT03862521

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes

Completed NA Last updated 25 May 2022

What this trial tests

NA trial testing Low carbohydrate diet in Type 1 Diabetes Mellitus in 16 participants. Completed in 28 February 2022.

Timeline

1 August 2018

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Nemours Children's Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 August 2018
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	1 location across United States

Drugs / interventions tested

Low carbohydrate diet
Very low carbohydrate diet

Conditions studied

Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
Diet Modification — all drugs for Diet Modification →
Child, Only — all drugs for Child, Only →

Sponsor

Nemours Children's Clinic

Who can join

Adults 2 to 11, any sex, with Type 1 Diabetes Mellitus or Diet Modification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to \<12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.

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:

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
NCT04228822 — Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes · NA · completed

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Nemours Children's Clinic trials

Trials by the same sponsor.

NCT06616818 — DASH Diet Intervention for Systemic Hypertension in Adolescents · NA · withdrawn
NCT07218588 — Sanctuary Farm Prescription in Adolescents · NA · recruiting
NCT06406621 — Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker · NA · recruiting
NCT07154667 — Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction · NA · recruiting
NCT07212049 — Ultrasound Use to Measure Magnetically Controlled Growing Rods · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03862521 (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 Nemours Children's Clinic
Last refreshed: 25 May 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/NCT03862521.

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