Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low carbohydrate diet group
Low carb diet, carbohydrates make up 30-40% of total daily calories.
|
Low carbohydrate diet
|
|
Experimental: Very low carbohydrate diet
Very low carb diet, carbohydrates make up 20-29% of total daily calories.
|
Very low carbohydrate diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline to 6 months
|
|
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
|
Baseline to 6 months
|
|
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
|
Baseline to 6 months
|
|
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
|
Change from baseline to 3 and 6 months
|
|
Change in lipid profile from baseline to 6 months
Time Frame: Baseline to 6 months
|
Change in lipid profile from baseline to 6 months
|
Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Larry A Fox, MD, Nemours Children's Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LowCHOT1D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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