[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493515":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Hypocaloric diet with predominance of animal protein",[13],"Behavioral: Control Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention","EXPERIMENTAL","Hypocaloric diet with predominance of plant protein",[19],"Behavioral: Plant-based Diet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Control Diet","Hypocaloric diet to achieve a 5% weight loss with macronutrient distribution according to current guidelines for T2D: 50% of energy from carbohydrates, prioritizing those with low glycemic index; 30% from total fats and a maximum of 10% from saturated fats; 20% of energy from proteins, 15% from animal sources and 5% from plant sources. Participants will also receive printed and validated educational material, with recommendations for healthy eating, and will be instructed to maintain their habitual physical activity level.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Plant-based Diet","Hypocaloric diet to achieve a 5% weight loss. The dietary prescription was adapted from the Eat-Lancet Commission report to Brazilian population culture, with 50% of energy from carbohydrates, prioritizing those with a low glycemic index; 30% from total fats and a maximum of 5% from saturated fats; 20% from proteins, 5% from animal sources and 15% from plant sources. Participants in this group will receive printed and validated support material with recommendations for a healthy and plant-based eating, and will be instructed to maintain their habitual physical activity level.",[15],[32],{"name":33,"affiliation":34,"role":35},"Fernando Gerchman, PhD","Hospital de Clínicas de Porto Alegre","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+555133596246","fgerchman@hcpa.edu.br",[42],{"facility":34,"status":43,"city":44,"state":45,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":49,"coordinates":50},"Point",[51,52],-51.23019,-30.03283,{"lat":52,"lon":51},[55],{"name":33,"role":38,"phone":56,"phoneExt":26,"email":40},"55 51 33598127",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[60],{"name":61,"class":62},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","OTHER_GOV","100493515","effect-of-partial-dietary-replacement-from-animal-to-plant-based-protein-for-type-2-diabetes-management-100493515",false,"NCT05706155","Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management","Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults (≥18 and ≤65 years old)\n* Diagnosis of Type 2 Diabetes;\n* Glycated hemoglobin from 7% to 11%;\n* Overweight or obesity (BMI ≥25 kg\u002Fm² and \\\u003C40 kg\u002Fm²);\n* Use of any hypoglycemic and insulin;\n* Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening;\n* Not having undergone dietary intervention in the last 6 months;\n* Have the ability to understand and be able to adhere to intervention proposals;\n* Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol;\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus;\n* Retinopathy with vision deficit that limits the activities proposed in the interventions;\n* Chronic kidney disease with estimated glomerular filtration \\\u003C 30 mL\u002Fmin per 1.73m²;\n* Liver failure, chronic viral hepatitis;\n* Grade III or IV heart failure\n* Active or progressive neurodegenerative disease;\n* Prior stroke that has caused sequelae;\n* Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss;\n* Chronic treatment with oral or parenteral corticosteroids (\\>7 days consecutive treatment) within 4 weeks prior to screening;\n* Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening;\n* Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening;\n* History of active substance abuse (including alcohol) within the last year;\n* Thyroid Stimulating Hormone (TSH) outside the normal range;\n* Fasting triglycerides ≥ 600 mg\u002FdL;\n* Tumor diagnosed and\u002For treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years;\n* Severe psychiatric illness;\n* Predisposition or diagnosis of eating disorders;\n* Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding;\n* Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and\u002For weight loss in the last 3 months;\n* Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma;\n* Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study;\n* Night workers who work after 10pm;\n* Being on a vegetarian, vegan or flexitarian diet at the time of recruitment;\n* Having undergone bariatric surgery;\n* Carriers of the human immunodeficiency virus (HIV);\n* Any other medical condition\u002Fdisorder 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;\n* Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.","ALL","18 Years","65 Years",{"count":74,"type":75},146,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82,83],"Type 2 Diabetes","Overweight","Obesity",[85,83,28,86],"Diabetes Mellitus","Insulin Resistance","2026-01-26",{"date":89,"type":90},"2026-01-29","ACTUAL",{"date":92,"type":90},"2022-11-01",{"date":94,"type":75},"2027-12-30",{"name":5,"class":6},1]