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

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

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.

Conditions4

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