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Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes

NCT04944316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-09-27

No results posted yet for this study

Summary

The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on the management of type 1 diabetes in adults. The primary outcome measure of this study is insulin requirements (measured as the total daily dose (TDD) of insulin or basal and bolus insulin units injected per day). The study duration is 12 weeks.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Dietary intervention

Low-fat, plant-based diet

BEHAVIORAL

Dietary intervention

Portion-controlled diet (compliant with ADA guidelines)

Sponsors & Collaborators

  • Physicians Committee for Responsible Medicine

    lead OTHER

Principal Investigators

  • Hana Kahleova, MD, PhD · Physicians Committee for Responsible Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2022-11-09
Completion
2022-11-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944316 on ClinicalTrials.gov