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

Not Applicable

Completed

• Conditions: Diet Modification; Type 1 Diabetes Mellitus; Child, Only
• Interventions: Other: Low carbohydrate diet; Other: Very low carbohydrate diet

• Registration Number: NCT03862521
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

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.

Detailed 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.

Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate diet group	Low carbohydrate diet	Low carb diet, carbohydrates make up 30-40% of total daily calories.
Very low carbohydrate diet	Very low carbohydrate diet	Very low carb diet, carbohydrates make up 20-29% of total daily calories.

Primary Outcome Measures

Name	Time	Method
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia	Baseline to 3 months	Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.

Secondary Outcome Measures

Name	Time	Method
Change in weight in kilograms from baseline to 6 months	Baseline to 6 months	Change in weight in kilograms from baseline to 6 months
Change in body composition from baseline to 6 months	Baseline to 6 months	Change in percent body fat using DXA scan from baseline to 6 months
Change in A1c from baseline to 3 and 6 months	Change from baseline to 3 and 6 months	Change in A1c over the length of the study
Change in height in centimeters from baseline to 6 months	Baseline to 6 months	Change in height in centimeters from baseline to 6 months
Change in lipid profile from baseline to 6 months	Baseline to 6 months	Change in lipid profile from baseline to 6 months

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States