Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

NCT04228822 | Completed DMC

• 1 other identifier: 201911121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Number of hypoglycemic events

  Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values \<70 mg/dL but ≥ 54 mg/dL and those \<54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values \<70 mg/dL but ≥ 54 mg/dL and \<54 mg/dL).

  6 month study period

• Episodes of diabetes related visits to the hospital, DKA

  Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.

  6 month study period

• Dyslipidemia

  Investigators will evaluate the changes in LDL levels among the study groups.

  6 month study period

Secondary Outcomes (2)

• Glycemic control

  6 month duration of the study

• Glucose variability

  6 month study period

Study Arms (2)

Low carb diet intervention group

EXPERIMENTAL

Low carbohydrate diet defined as 25-35% of total energy intake

Other: Low carbohydrate diet

Control

NO INTERVENTION

Standard diet defined as 45-65% total energy intake

Interventions

Low carbohydrate diet OTHER

25-35% of carbohydrates from total energy intake

Low carb diet intervention group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
• No carbohydrate restrictions at the time of recruitment.
• No medications that could affect appetite
• Regular attendance at the clinic (3-4 times per year),
• Glycated hemoglobin (HbA1c) \<10%.

You may not qualify if:

• Impaired renal or liver function,
• Chronic seizures or global developmental delay,
• Diagnosed with ADHD and/or on ADHD medications
• Use of drugs other than insulin affecting glucose metabolism
• Severe eczema
• Celiac disease

Sponsors & Collaborators

• Washington University School of Medicine: lead
• ICTS BJH: collaborator
• Center for Diabetes Translation Research: collaborator

Study Sites (1)

St Louis Children's Hospital

St Louis, Missouri, 63110, 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 Design

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

Model Details: 20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 14, 2020
• Study Start: November 10, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)