Status:
COMPLETED
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Type 1 Diabetes Mellitus
Diet Modification
Eligibility:
All Genders
2-11 years
Phase:
NA
Brief 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 ran...
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 ran...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03862521
Start Date
August 1 2018
End Date
February 28 2022
Last Update
May 25 2022
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207