Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes
ID: NCT04874012
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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.
Read Full Scientific Objectives & Methods
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.
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
Treatment Arms Description
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 6 gy taurine divided into twice/day orally administration for 12 weeks.
- 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%.
- 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.
Primary Outcome Measures
- HbA1c — Time Frame: baseline and 12 weeks
Changes from baseline glycated hemoglobin levels at 12 weeks
View Secondary Outcome Measures (9)
- Fasting glucose — Time Frame: baseline and 12 weeks
Changes from baseline fasting glucose levels at 12 weeks
- Insulin levels — Time Frame: baseline and12 weeks
Changes from baseline insulin levels at 12 weeks
- Total serum cholesterol (CT) and fractions — Time Frame: 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 — Time Frame: baseline and12 weeks
Changes from baseline triglycerides serum levels at 12 weeks
- Glucose variability — Time Frame: for 2 weeks (10-12th week)
Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)
- Cytokine levels — Time Frame: baseline and 12 weeks
Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks
- Protein creatine index — Time Frame: baseline and 12 weeks
Changes from baseline protein creatinine index measured in urine at 12 weeks.
- Albuminuria — Time Frame: baseline and 12 weeks
Changes from baseline albuminuria levels at 12 weeks
- Body mass index (BMI) — Time Frame: baseline and 4, 8, and 12 weeks
Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- Caletti G, Herrmann AP, Pulcinelli RR, Steffens L, Moras AM, Vianna P, Chies JAB, Moura DJ, Barros HMT, Gomez R. Taurine counteracts the neurotoxic effects of streptozotocin-induced diabetes in rats. Amino Acids. 2018 Jan;50(1):95-104. doi: 10.1007/s00726-017-2495-1. Epub 2017 Sep 21.PubMed ↗
- Caletti G, Olguins DB, Pedrollo EF, Barros HM, Gomez R. Antidepressant effect of taurine in diabetic rats. Amino Acids. 2012 Oct;43(4):1525-33. doi: 10.1007/s00726-012-1226-x.PubMed ↗
- Chauncey KB, Tenner TE Jr, Lombardini JB, Jones BG, Brooks ML, Warner RD, Davis RL, Ragain RM. The effect of taurine supplementation on patients with type 2 diabetes mellitus. Adv Exp Med Biol. 2003;526:91-6. doi: 10.1007/978-1-4615-0077-3_12. No abstract available.PubMed ↗
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.PubMed ↗
- Fukuda N, Yoshitama A, Sugita S, Fujita M, Murakami S. Dietary taurine reduces hepatic secretion of cholesteryl ester and enhances fatty acid oxidation in rats fed a high-cholesterol diet. J Nutr Sci Vitaminol (Tokyo). 2011;57(2):144-9. doi: 10.3177/jnsv.57.144.PubMed ↗
View Official Medical/Scientific Title
Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial