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Completed

NCT Number: NCT03862521

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Child, Only Diabetes Mellitus Diabetes Mellitus, Type 1 Diet Modification Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate diet

Other

Low carbohydrate diet

Very low carbohydrate diet

Other

Very low carbohydrate diet

Primary outcomes

  1. Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia

    Time frame: Baseline to 3 months

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

Secondary outcomes

  1. Change in height in centimeters from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in height in centimeters from baseline to 6 months

  2. Change in weight in kilograms from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in weight in kilograms from baseline to 6 months

  3. Change in body composition from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in percent body fat using DXA scan from baseline to 6 months

  4. Change in A1c from baseline to 3 and 6 months

    Time frame: Change from baseline to 3 and 6 months

    Change in A1c over the length of the study

  5. Change in lipid profile from baseline to 6 months

    Time frame: Baseline to 6 months

    Change in lipid profile from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2019
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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