PMID- 36047065 OWN - NLM STAT- MEDLINE DCOM- 20230508 LR - 20230515 IS - 1475-2662 (Electronic) IS - 0007-1145 (Linking) VI - 129 IP - 11 DP - 2023 Jun 14 TI - Effect of taurine on glycaemic, lipid and inflammatory profile in individuals with type 2 diabetes: study protocol of a randomised trial. PG - 1871-1876 LID - 10.1017/S0007114522002768 [doi] AB - Type 2 diabetes mellitus (T2DM) is characterised by chronic hyperglycaemia. Despite the efficacy of conventional pharmacotherapy, some individuals do not reach glycaemic goals and require adjuvant therapies. Taurine, a semi-essential amino acid, decreases blood glucose and cholesterol levels in rodents and humans. However, glycated hemoglobin (HbA1c) has not been evaluated in randomised controlled trials after taurine treatment for more than 12 weeks. This study aims to evaluate the effect of taurine administration on glycaemic, lipid, inflammatory, anthropometric and dietary parameters in individuals with T2DM. A randomised, double-blind, placebo-controlled clinical trial will be conducted at the Clinical Research Center of a tertiary public hospital. Participants with T2DM (n 94) will be recruited and randomised to receive 3 g of taurine or placebo, twice/day, orally, for 12 weeks. Blood samples will be collected before and after 12 weeks of treatment, when HbA1c, fasting glucose, insulin, albuminuria, creatinine, total cholesterol and fractions, triglycerides, C-reactive protein, TNF-alpha, IL 1, 4, 5, 6, 10 and 13 will be evaluated. Anthropometric parameters and 24-hour food recall will also be evaluated. The study will evaluate the effect of taurine treatment on biochemical and anthropometric parameters in individuals with T2DM. These results will guide the decision-making to indicate taurine treatment as an adjunct in individuals with T2DM who have not reached their glycaemic goal. FAU - Caletti, Greice AU - Caletti G AD - Universidade Federal do Rio Grande do Sul, Medical School, Porto Alegre, Brazil. AD - Hospital de Clinicas de Porto Alegre, Endocrine Division, Porto Alegre, Brazil. FAU - Cardoso, Monique Vargas AU - Cardoso MV AD - Faculdades Integradas de Taquara, Taquara, Brazil. FAU - Scheffel, Rafael Selbach AU - Scheffel RS AD - Universidade Federal do Rio Grande do Sul, Medical School, Porto Alegre, Brazil. AD - Hospital de Clinicas de Porto Alegre, Endocrine Division, Porto Alegre, Brazil. AD - Universidade Federal do Rio Grande do Sul, Departament of Pharmacology, Instituto de Ciencias Basicas da Saude, Porto Alegre, Brazil. FAU - Schaan, Beatriz D AU - Schaan BD AD - Universidade Federal do Rio Grande do Sul, Medical School, Porto Alegre, Brazil. AD - Hospital de Clinicas de Porto Alegre, Endocrine Division, Porto Alegre, Brazil. FAU - Gomez, Rosane AU - Gomez R AD - Universidade Federal do Rio Grande do Sul, Departament of Pharmacology, Instituto de Ciencias Basicas da Saude, Porto Alegre, Brazil. FAU - Bock, Patricia Martins AU - Bock PM AUID- ORCID: 0000-0001-8572-3950 AD - Universidade Federal do Rio Grande do Sul, Departament of Pharmacology, Instituto de Ciencias Basicas da Saude, Porto Alegre, Brazil. AD - Faculdades Integradas de Taquara, Taquara, Brazil. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220901 PL - England TA - Br J Nutr JT - The British journal of nutrition JID - 0372547 RN - 0 (Glycated Hemoglobin) RN - 0 (Blood Glucose) RN - 0 (Lipids) RN - 97C5T2UQ7J (Cholesterol) SB - IM MH - Humans MH - *Diabetes Mellitus, Type 2/drug therapy MH - Glycated Hemoglobin MH - Blood Glucose/metabolism MH - Double-Blind Method MH - Lipids MH - Cholesterol MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Cholesterol OT - Cytokines OT - Diabetes mellitus OT - Glycated hemoglobin OT - Hyperglycaemia OT - Taurine EDAT- 2022/09/02 06:00 MHDA- 2023/05/08 10:17 CRDT- 2022/09/01 03:33 PHST- 2023/05/08 10:17 [medline] PHST- 2022/09/02 06:00 [pubmed] PHST- 2022/09/01 03:33 [entrez] AID - S0007114522002768 [pii] AID - 10.1017/S0007114522002768 [doi] PST - ppublish SO - Br J Nutr. 2023 Jun 14;129(11):1871-1876. doi: 10.1017/S0007114522002768. Epub 2022 Sep 1.