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

NCT ID: NCT03862521

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-02-28

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.

Conditions

Type 1 Diabetes Mellitus; Diet Modification; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low carbohydrate diet group

Low carb diet, carbohydrates make up 30-40% of total daily calories.

Group Type: EXPERIMENTAL

Low carbohydrate diet

Intervention Type: OTHER

Low carbohydrate diet

Very low carbohydrate diet

Very low carb diet, carbohydrates make up 20-29% of total daily calories.

Group Type: EXPERIMENTAL

Very low carbohydrate diet

Intervention Type: OTHER

Very low carbohydrate diet

Interventions

Low carbohydrate diet

Low carbohydrate diet

Intervention Type: OTHER

Very low carbohydrate diet

Very low carbohydrate diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry A Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health

Locations

Nemours Children's Clinic

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

LowCHOT1D

Identifier Type: -

Identifier Source: org_study_id