Status:
COMPLETED
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
13-25 years
Phase:
NA
Brief Summary
This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.
Detailed Description
First, to evaluate the feasibility of following each type of VLCD (high protein or high fat), participants will follow a standard carbohydrate diet for 2 weeks, followed by a 1 week transition to a VL...
Eligibility Criteria
Inclusion
- BMI 19-30 m2 for individuals at least 18 years old or BMI \< 95 percentile for individuals less than 18 years old
- Participants 18 years of age must be able to read and provide written consent
- Participants under 18 years of age must be able to read and provide written assent
- Participants are managed using an insulin pump or injections
- Participant has or is willing to wear a CGM for the duration of the study
- Participant is willing to complete diet logging procedures stated above
Exclusion
- A1c \< 6.5% or \> 10%
- Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
- Treatment with glucose-lowering drugs other than insulin
- Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
- Weight loss medications within the last 6 months
- Females who are pregnant, lactating or planning to become pregnant in the next 6 months
- Another medical condition that precludes participation in the study
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04082884
Start Date
June 25 2020
End Date
February 20 2022
Last Update
February 15 2024
Active Locations (1)
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1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06511