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

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how changing some animal protein in one's diet to plant-based protein can help manage blood sugar levels and other health issues for people with type 2 diabetes who are overweight or obese. For 24 weeks, participants will follow either a plant-based diet or a standard healthy diet, while continuing their usual physical activity. The researchers want to see if the plant-based diet makes a difference in managing diabetes.

To be eligible for this study, you need to be an adult between 18 and 65 years old, have a diagnosis of type 2 diabetes, and be overweight or obese. You should also have stable blood sugar levels and not have made any recent major changes to your diet. Participants will need to be able to understand the study’s requirements and agree to follow them. If you're interested, this trial could be a great opportunity to contribute to understanding better dietary choices for managing diabetes.

Gender

ALL

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.