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Recruiting NCT05706155

Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management

Trial Parameters

Condition Type 2 Diabetes
Sponsor Hospital de Clinicas de Porto Alegre
Study Type INTERVENTIONAL
Phase N/A
Enrollment 146
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2022-11-01
Completion 2027-12-30
Interventions
Control DietPlant-based Diet

Brief Summary

The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.

Eligibility Criteria

Inclusion Criteria: * Adults (≥18 and ≤65 years old) * Diagnosis of Type 2 Diabetes; * Glycated hemoglobin from 7% to 11%; * Overweight or obesity (BMI ≥25 kg/m² and \<40 kg/m²); * Use of any hypoglycemic and insulin; * Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening; * Not having undergone dietary intervention in the last 6 months; * Have the ability to understand and be able to adhere to intervention proposals; * Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol; Exclusion Criteria: * Type 1 diabetes mellitus; * Retinopathy with vision deficit that limits the activities proposed in the interventions; * Chronic kidney disease with estimated glomerular filtration \< 30 mL/min per 1.73m²; * Liver failure, chronic viral hepatitis; * Grade III or IV heart failure * Active or progressive neurodegenerative disease; * Prior stroke that has caused sequelae; * Use of medication

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