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NCT Number: NCT04228822

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

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.

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Key information

Conditions

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

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

About this study

The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.

During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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

Treatment and study plan

Low carbohydrate diet

Other

25-35% of carbohydrates from total energy intake

Primary outcomes

  1. Number of hypoglycemic events

    Time frame: 6 month study period

    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).

  2. Episodes of diabetes related visits to the hospital, DKA

    Time frame: 6 month study period

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

  3. Dyslipidemia

    Time frame: 6 month study period

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

Secondary outcomes

  1. Glycemic control

    Time frame: 6 month duration of the study

    Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.

  2. Glucose variability

    Time frame: 6 month study period

    Using CGM data investigators will evaluate glucose variability using standard deviation (SD) of all glucose values. Secondary endpoints will include time of the day spent in range (values between 70-140 mg/dl and between 70 and 180mg/dl), in hypoglycemia (values <70 mgl/dl but ≥ 54 mg/dl and <54 mg/dl) and in hyperglycemia (values >180mg/dl and >250 mg/dl).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Center for Diabetes Translation Research
  • ICTS BJH

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2020
Registry last updated
Mar 9, 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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