An interventional study of Low carbohydrate diet and Very low carbohydrate diet in Type 1 Diabetes Mellitus, Diet Modification and Child, Only, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion criteria
Low carb diet, carbohydrates make up 30-40% of total daily calories.
Other: Low carbohydrate diet
Very low carb diet, carbohydrates make up 20-29% of total daily calories.
Other: Very low carbohydrate diet
Low carbohydrate diet
Very low carbohydrate diet
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.
Time frame: Baseline to 3 months
Change in height in centimeters from baseline to 6 months
Change in height in centimeters from baseline to 6 months
Time frame: Baseline to 6 months
Change in weight in kilograms from baseline to 6 months
Change in weight in kilograms from baseline to 6 months
Time frame: Baseline to 6 months
Change in body composition from baseline to 6 months
Change in percent body fat using DXA scan from baseline to 6 months
Time frame: Baseline to 6 months
Change in A1c from baseline to 3 and 6 months
Change in A1c over the length of the study
Time frame: Change from baseline to 3 and 6 months
Change in lipid profile from baseline to 6 months
Change in lipid profile from baseline to 6 months
Time frame: Baseline to 6 months
Plan to share: No
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Nemours Children's Clinic