Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle.
干预措施: Placebo Comparator (Other)
Taurine
Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.
干预措施: Active comparator Taurine (Drug)
结局指标
主要结局
HbA1c
时间窗: baseline and 12 weeks
Changes from baseline glycated hemoglobin levels at 12 weeks
次要结局
- Albuminuria(baseline and 12 weeks)
- Insulin levels(baseline and12 weeks)
- Protein creatine index(baseline and 12 weeks)
- Fasting glucose(baseline and 12 weeks)
- Body mass index (BMI)(baseline and 4, 8, and 12 weeks)
- Total serum cholesterol (CT) and fractions(baseline and12 weeks)
- Triglycerides serum levels(baseline and12 weeks)
- Glucose variability(for 2 weeks (10-12th week))
- Cytokine levels(baseline and 12 weeks)