Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes (TAUGLIP-DM2)

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

A randomized, double-blind, placebo-controlled clinical trial will be conducted at Hospital de Clínicas de Porto Alegre (HCPA), Brazil. A total of 94 participants with DM2 will be recruited and randomized on a 1:1 ratio to receive 3 g taurine as a powder for oral suspension, twice per day, for 12 weeks or packets containing placebo. Blood will be collected prior to the treatment and after 12 weeks for glycated hemoglobin, fasting glucose, insulinemia, total cholesterol and fractions, triglycerides, C-reactive protein, creatinine, urea, tumor necrosis factor-alpha (TNF-α), interleukin 1 and 6 (IL-1 and IL-6) measures. Urine will be collected at baseline and after 12 weeks for creatine, protein, and albumin measured. Anthropometric parameters and a 24-h dietary recall will be monthly investigated. Fourteen days before the end of the trial, participants will be connected to a continuous glucose monitoring system for glucose monitoring system for glucose variability evaluation. Participants will be contacted by phone weekly to report adverse effects.

taurine, inflammation, glucose metabolism disorders, glycated hemoglobin, diabetes mellitus, type 2, amino acids

The generation of the sequence of numbers will be done by a blinded researcher, after selecting the participant by the inclusion and exclusion criteria. The concealment of allocation will be implemented by a central randomization routine, conducted by researchers with access to the list and by the researcher responsible for requesting the code for placement of individuals in the study.

Participants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle.

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.

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

Changes from baseline total serum cholesterol, high-density lipoprotein (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels at 12 weeks

Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)

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.

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