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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
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
Hospital de Clínicas
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGHbA1c
Changes from baseline glycated hemoglobin levels at 12 weeks
Time frame: baseline and 12 weeks
Fasting glucose
Changes from baseline fasting glucose levels at 12 weeks
Time frame: baseline and 12 weeks
Insulin levels
Changes from baseline insulin levels at 12 weeks
Time frame: baseline and12 weeks
Total serum cholesterol (CT) and fractions
Changes from baseline total serum cholesterol, high-density lipoprotein (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels at 12 weeks
Time frame: baseline and12 weeks
Triglycerides serum levels
Changes from baseline triglycerides serum levels at 12 weeks
Time frame: baseline and12 weeks
Glucose variability
Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)
Time frame: for 2 weeks (10-12th week)
Cytokine levels
Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks
Time frame: baseline and 12 weeks
Protein creatine index
Changes from baseline protein creatinine index measured in urine at 12 weeks.
Time frame: baseline and 12 weeks
Albuminuria
Changes from baseline albuminuria levels at 12 weeks
Time frame: baseline and 12 weeks
Body mass index (BMI)
Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks.
Time frame: baseline and 4, 8, and 12 weeks
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