NCT05706155 Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
| NCT ID | NCT05706155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2022-11-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Fernando Gerchman, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT05706155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05706155 currently recruiting?
Yes, NCT05706155 is actively recruiting participants. Contact the research team at fgerchman@hcpa.edu.br for enrollment information.
Where is the NCT05706155 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT05706155 clinical trial?
NCT05706155 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Fernando Gerchman, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 146 participants.
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