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Low carbohydrate diet group for Type 1 Diabetes

N/A
Waitlist Available
Led By Larry A Fox, MD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 and 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Type 1 Diabetes
  • Diet Modification
  • Childhood

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia
Secondary outcome measures
Change in A1c from baseline to 3 and 6 months
Change in body composition from baseline to 6 months
Change in height in centimeters from baseline to 6 months
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Very low carbohydrate dietExperimental Treatment1 Intervention
Very low carb diet, carbohydrates make up 20-29% of total daily calories.
Group II: Low carbohydrate diet groupExperimental Treatment1 Intervention
Low carb diet, carbohydrates make up 30-40% of total daily calories.

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
124 Previous Clinical Trials
18,115 Total Patients Enrolled
Larry A Fox, MDPrincipal InvestigatorNemours Children's Health
3 Previous Clinical Trials
28 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
2018. "Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03862521.
~2 spots leftby Apr 2025
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