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

NCT03862521 | Completed

• 1 other identifier: LowCHOT1D
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Diet Modification; Child, Only

Keywords

type 1 diabetes; low carbohydrate diets; insulin pump therapy; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in height in centimeters from baseline to 6 months

  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

  Baseline to 6 months

• Change in A1c from baseline to 3 and 6 months

  Change from baseline to 3 and 6 months

• Change in lipid profile from baseline to 6 months

  Baseline to 6 months

Study Arms (2)

Low carbohydrate diet group

EXPERIMENTAL

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

Other: Low carbohydrate diet

Very low carbohydrate diet

EXPERIMENTAL

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

Other: Very low carbohydrate diet

Interventions

Low carbohydrate diet OTHER

Low carbohydrate diet

Low carbohydrate diet group

Very low carbohydrate diet OTHER

Very low carbohydrate diet

Very low carbohydrate diet

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Larry A Fox, MD

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized to either low or very low carbohydrate diet

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 5, 2019
• Study Start: August 1, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)