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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Active comparator Taurine
DrugParticipants 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.
Placebo Comparator
Other interventionParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
HbA1c
Changes from baseline glycated hemoglobin levels at 12 weeks
Secondary outcomes
Fasting glucose
Changes from baseline fasting glucose levels at 12 weeks
Insulin levels
Changes from baseline insulin levels at 12 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
Triglycerides serum levels
Changes from baseline triglycerides serum levels at 12 weeks
Sponsors and contacts
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