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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus, Diet Modification, Child, Only

In brief

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.

Key facts

Study ID

NCT03862521

Run by

Nemours Children's Clinic

People needed

16

Starts

2018-08-01

Expected to finish

2022-02-28

Last updated by the study team

2022-05-25

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prepubertal children 2 to <12 years old (i.e., before 12th birthday)
• Type 1 diabetes for at least 6 months
• Patients must be using insulin pump therapy
• Not presently on low carbohydrate diet

You may not qualify if…

• On low or very low carbohydrate diet
• History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
• History of metabolic disorder affection lipid metabolism
• Severe hypoglycemic event in past 3 months

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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