RECRUITINGPhase 2INTERVENTIONAL

Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes

Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Active comparator Taurine

Participants will receive 3 g taurine, twice a day, as a powder for oral suspension (3 g/packet) for 12 weeks. Participants will be recommended to take the taurine immediately before the breakfast and dinner.

OTHER

Placebo Comparator

Participants will receive the same treatment regimen and intake recommendation, but packets with the same appearance and size from those taurine ones will contain a vehicle

Locations (1)

Hospital de Clínicas

Porto Alegre, Rio Grande do Sul, Brazil