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New treatment option for Type 2 Diabetes
Official title Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
ClinicalTrials.gov ID: NCT05706155
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.