NCT04874012 Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes
| NCT ID | NCT04874012 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2021-06-12 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 94 participants in total. It began in 2021-06-12 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Type 2 diabetes mellitus (DM2) is characterized by chronic hyperglycemia, which is a risk factor for comorbidities and death. Although conventional pharmacotherapy is effective, some individuals do not reach the glycemic targets, requiring adjuvant therapies. Taurine is a semi-essential amino acid with antioxidant and osmoregulatory properties, commonly used as a nutritional supplement. Pre-clinical studies show its effectiveness in reducing blood glucose and cholesterol, but there are no well-conducted clinical studies evaluating the effect of taurine on glycated hemoglobin. Additionally, animal models showed that taurine had a protective effect from diabetic nephropathy. The hypothesize of this study is that taurine administration improves the glycemic, lipid, inflammatory, and anthropometric parameters in DM2 individuals.
Eligibility Criteria
Inclusion criteria * Female and male individuals, with clinical diagnosis of DM2 for at least 6 months; * Age over 30 years; * BMC equal to or above 18.5 kg/m2, without weight change in the last 3 months; * HbA1c between 7.5% and 10.5%. Exclusion criteria * Use of herbal supplements, antioxidants, and multivitamins in the last 3 months; * Pregnancy or lactation; * Chronic renal failure with glomerular filtration rate calculated by MDRD \< 30 mL/h; * Myocardial infarction in the last than 6 months * Current neoplasia; * Chronic use of glucocorticoids; * Bariatric surgery.
Contact & Investigator
Beatriz D Schaan, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT04874012 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04874012 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04874012 currently recruiting?
Yes, NCT04874012 is actively recruiting participants. Contact the research team at bschaan@hcpa.edu.br for enrollment information.
Where is the NCT04874012 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT04874012 clinical trial?
NCT04874012 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Beatriz D Schaan, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 94 participants.
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