Actively Recruiting
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-01-29
146
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
H
Hospital de Clinicas de Porto Alegre
Lead Sponsor
C
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 to 65 years old)
- Diagnosis of Type 2 Diabetes
- Glycated hemoglobin from 7% to 11%
- Overweight or obesity (BMI between 25 kg/m2 and less than 40 kg/m2)
- Use of any hypoglycemic and insulin
- Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening
- No dietary intervention in the last 6 months
- Ability to understand and adhere to intervention proposals
- Able and willing to provide written informed consent and comply with study requirements
You will not qualify if you...
- Type 1 diabetes mellitus
- Retinopathy causing vision deficit limiting intervention activities
- Chronic kidney disease with estimated glomerular filtration rate less than 30 mL/min per 1.73m2
- Liver failure or chronic viral hepatitis
- Grade III or IV heart failure
- Active or progressive neurodegenerative disease
- Prior stroke causing sequelae
- Use of medications affecting glucose metabolism or causing weight loss
- Chronic corticosteroid treatment (>7 days consecutive) within 4 weeks before screening
- Treatment with weight-reducing agents within last 12 weeks before screening
- Unstable thyroid hormone treatment in last 12 weeks before screening
- Active substance abuse within last year
- Thyroid Stimulating Hormone (TSH) outside normal range
- Fasting triglycerides ≥ 600 mg/dL
- Tumor diagnosed or treated within last 5 years (except some skin and in situ cancers)
- Severe psychiatric illness
- Predisposition or diagnosis of eating disorders
- Women who are pregnant, intend to become pregnant, or breastfeeding
- Acute hyperglycemia symptoms in last 3 months
- Metabolic or acute diabetes complications
- Unreliable patients or deemed unsuitable by investigator
- Night workers working after 10pm
- On vegetarian, vegan, or flexitarian diet at recruitment
- History of bariatric surgery
- HIV carriers
- Any medical condition interfering with study participation
- Requirement for treatment affecting study data reliability or safety during intervention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
Research Team
F
Fernando Gerchman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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