Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals with Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: Placebo Comparator
- Registration Number
- NCT04874012
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Comparator Participants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle. Taurine Active comparator Taurine Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.
- Primary Outcome Measures
Name Time Method HbA1c baseline and 12 weeks Changes from baseline glycated hemoglobin levels at 12 weeks
- Secondary Outcome Measures
Name Time Method Insulin levels baseline and12 weeks Changes from baseline insulin levels at 12 weeks
Protein creatine index baseline and 12 weeks Changes from baseline protein creatinine index measured in urine at 12 weeks.
Fasting glucose baseline and 12 weeks Changes from baseline fasting glucose levels at 12 weeks
Albuminuria baseline and 12 weeks Changes from baseline albuminuria levels at 12 weeks
Body mass index (BMI) baseline and 4, 8, and 12 weeks Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks.
Total serum cholesterol (CT) and fractions baseline and12 weeks 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 baseline and12 weeks Changes from baseline triglycerides serum levels at 12 weeks
Glucose variability for 2 weeks (10-12th week) Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)
Cytokine levels baseline and 12 weeks Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks
Trial Locations
- Locations (1)
Hospital de Clínicas
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil