[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429587":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":57,"studyPopulation":44,"armGroups":58,"interventions":71,"overallOfficials":82,"centralContacts":86,"locations":95,"responsibleParty":115,"collaborators":44,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":44,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":98,"whyStopped":44,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"HbA1c","Changes from baseline glycated hemoglobin levels at 12 weeks","baseline and 12 weeks",[14,17,21,24,27,31,34,37,40],{"measure":15,"description":16,"timeFrame":12},"Fasting glucose","Changes from baseline fasting glucose levels at 12 weeks",{"measure":18,"description":19,"timeFrame":20},"Insulin levels","Changes from baseline insulin levels at 12 weeks","baseline and12 weeks",{"measure":22,"description":23,"timeFrame":20},"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",{"measure":25,"description":26,"timeFrame":20},"Triglycerides serum levels","Changes from baseline triglycerides serum levels at 12 weeks",{"measure":28,"description":29,"timeFrame":30},"Glucose variability","Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)","for 2 weeks (10-12th week)",{"measure":32,"description":33,"timeFrame":12},"Cytokine levels","Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks",{"measure":35,"description":36,"timeFrame":12},"Protein creatine index","Changes from baseline protein creatinine index measured in urine at 12 weeks.",{"measure":38,"description":39,"timeFrame":12},"Albuminuria","Changes from baseline albuminuria levels at 12 weeks",{"measure":41,"description":42,"timeFrame":43},"Body mass index (BMI)","Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks.","baseline and 4, 8, and 12 weeks",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","Randomized, double-blind, placebo-controlled clinical trial","TREATMENT",{"masking":51,"maskingDescription":52,"whoMasked":53},"TRIPLE","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.",[54,55,56],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"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.",[64],"Other: Placebo Comparator",{"label":66,"type":67,"description":68,"interventionNames":69},"Taurine","ACTIVE_COMPARATOR","Participants will receive 6 gy taurine divided into twice\u002Fday orally administration for 12 weeks.",[70],"Drug: Active comparator Taurine",[72,78],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","Active comparator Taurine","Participants will receive 3 g taurine, twice a day, as a powder for oral suspension (3 g\u002Fpacket) for 12 weeks. Participants will be recommended to take the taurine immediately before the breakfast and dinner.",[66],[66],{"type":6,"name":79,"description":80,"armGroupLabels":81,"otherNames":44},"Placebo Comparator","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",[60],[83],{"name":84,"affiliation":5,"role":85},"Beatriz D Schaan, PhD","PRINCIPAL_INVESTIGATOR",[87,91],{"name":84,"role":88,"phone":89,"phoneExt":44,"email":90},"CONTACT","55 51 3359-8000","bschaan@hcpa.edu.br",{"name":92,"role":88,"phone":93,"phoneExt":44,"email":94},"Rosane Gomez, PhD","55 51 33082823","rogomez@hcpa.edu.br",[96],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Hospital de Clínicas","RECRUITING","Porto Alegre","Rio Grande do Sul","90630090","Brazil","BR",{"type":105,"coordinates":106},"Point",[107,108],-51.23019,-30.03283,{"lat":108,"lon":107},[111,114],{"name":112,"role":88,"phone":113,"phoneExt":44,"email":90},"Beatriz D'agord Schaan, PhD","55+513359-8000",{"name":92,"role":88,"phone":93,"phoneExt":44,"email":94},{"type":116,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100429587","phase-2-taurine-effect-on-glycemic-lipidic-and-inflammatory-profile-in-individuals-with-type-2-diabetes-100429587",false,"NCT04874012","Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes","Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial","TAUGLIP-DM2","Inclusion criteria\n\n* Female and male individuals, with clinical diagnosis of DM2 for at least 6 months;\n* Age over 30 years;\n* BMC equal to or above 18.5 kg\u002Fm2, without weight change in the last 3 months;\n* HbA1c between 7.5% and 10.5%.\n\nExclusion criteria\n\n* Use of herbal supplements, antioxidants, and multivitamins in the last 3 months;\n* Pregnancy or lactation;\n* Chronic renal failure with glomerular filtration rate calculated by MDRD \\\u003C 30 mL\u002Fh;\n* Myocardial infarction in the last than 6 months\n* Current neoplasia;\n* Chronic use of glucocorticoids;\n* Bariatric surgery.","ALL","30 Years","80 Years",{"count":129,"type":130},94,"ESTIMATED","INTERVENTIONAL",[133],"PHASE2","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.",[136],"Diabetes Mellitus, Type 2",[138,139,140,141,142,143],"taurine","inflammation","glucose metabolism disorders","glycated hemoglobin","diabetes mellitus, type 2","amino acids","2026-09-21",{"date":146,"type":147},"2026-09-24","ACTUAL",{"date":149,"type":147},"2021-06-12",{"date":151,"type":130},"2026-12-01",{"name":5,"class":6},1]