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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Low carbohydrate diet
* Other: Very low carbohydrate diet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized to either low or very low carbohydrate diet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate diet group<br>Low carb diet, carbohydrates make up 30-40% of total daily calories. | Other: Low carbohydrate diet<br>* Low carbohydrate diet<br>|
| Experimental: Very low carbohydrate diet<br>Very low carb diet, carbohydrates make up 20-29% of total daily calories. | Other: Very low carbohydrate diet<br>* Very low carbohydrate diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia | Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in height in centimeters from baseline to 6 months | Change in height in centimeters from baseline to 6 months | Baseline to 6 months | 
| Change in weight in kilograms from baseline to 6 months | Change in weight in kilograms from baseline to 6 months | Baseline to 6 months | 
| Change in body composition from baseline to 6 months | Change in percent body fat using DXA scan from baseline to 6 months | Baseline to 6 months | 
| Change in A1c from baseline to 3 and 6 months | Change in A1c over the length of the study | Change from baseline to 3 and 6 months | 
| Change in lipid profile from baseline to 6 months | Change in lipid profile from baseline to 6 months | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, low carbohydrate diets, insulin pump therapy, continuous glucose monitoring