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Recruiting
NCT05706155
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
Conditions: Type 2 Diabetes, Overweight, Obesity
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 140
Sponsor: Hospital de Clinicas de Porto Alegre
Location: Brazil
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 failureActive or progressive neurodegenerative disease;Prior stroke that has caused sequelae;Use of medications that affect glucose metabolism (e.g.
corticosteroids or immunosuppressants) or cause weight loss;Chronic treatment with oral or parenteral corticosteroids (>7 days consecutive treatment) within 4 weeks prior to screening;Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening;Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening;History of active substance abuse (including alcohol) within the last year;Thyroid Stimulating Hormone (TSH) outside the normal range;Fasting triglycerides ≥ 600 mg/dL;Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years;Severe psychiatric illness;Predisposition or diagnosis of eating disorders;Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding;Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months;Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma;Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study;Night workers who work after 10pm;Being on a vegetarian, vegan or flexitarian diet at the time of recruitment;Having undergone bariatric surgery;Carriers of the human immunodeficiency virus (HIV);Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities;Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.
Source: ClinicalTrials.gov (NCT05706155). StuddyBuddy aggregates publicly available trial information.