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Very Low Carbohydrate Diet for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks per intervention, up to 7 weeks
Awards & highlights

Study Summary

This trial is testing whether a very low carbohydrate diet can help improve glycemic and metabolic control in youth with Type 1 Diabetes.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks per intervention, up to 7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks per intervention, up to 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time in Target Range of 70-180 mg/dL.
Secondary outcome measures
Average Sensor Glucose Level
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Very Low Carbohydrate DietExperimental Treatment1 Intervention
Participants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high protein very low carbohydrate diet (VLCD) which will be 11% of caloric intake from carbohydrates, 23% of calories from protein, and 66% of calories from fat.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Very Low Carbohydrate Diet
2020
N/A
~10

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,846 Previous Clinical Trials
2,736,473 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,354 Previous Clinical Trials
4,315,321 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
2020. "Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04082884.
~1 spots leftby Apr 2025
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