Plant protein swap may tame blood sugar in type 2 diabetes
NCT ID NCT05706155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether partly replacing animal protein with plant protein can improve blood sugar control in people with type 2 diabetes who are overweight. About 146 adults will follow either a plant-based diet or a standard healthy diet for 24 weeks. The main goal is to see if the plant-based diet lowers glycated hemoglobin, a key measure of long-term blood sugar.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital de Clínicas de Porto Alegre
RECRUITINGPorto Alegre, Rio Grande do Sul, Brazil
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