Hospital de Clínicas
Porto Alegre, Rio Grande do Sul, 90630090, Brazil
Location status: Recruiting
Location contact
Beatriz D'agord Schaan, PhD
CONTACT
55+513359-8000
Rosane Gomez, PhD
CONTACT
NCT Number: NCT04874012
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.
Interested in participating?
Request Info30 year–80 year
All sexes
Interventional
Phase 2
Porto Alegre, Rio Grande do Sul, 90630090, Brazil
Location status: Recruiting
Beatriz D'agord Schaan, PhD
CONTACT
55+513359-8000
Rosane Gomez, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Taurine
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
Time frame: baseline and 12 weeks
Changes from baseline glycated hemoglobin levels at 12 weeks
Time frame: baseline and 12 weeks
Changes from baseline fasting glucose levels at 12 weeks
Time frame: baseline and12 weeks
Changes from baseline insulin levels at 12 weeks
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
Time frame: baseline and12 weeks
Changes from baseline triglycerides serum levels at 12 weeks
Time frame: for 2 weeks (10-12th week)
Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)
Time frame: baseline and 12 weeks
Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks
Time frame: baseline and 12 weeks
Changes from baseline protein creatinine index measured in urine at 12 weeks.
Time frame: baseline and 12 weeks
Changes from baseline albuminuria levels at 12 weeks
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.
Contact information is provided by the study sponsor or research team.
Beatriz D Schaan, PhD
CONTACT
Rosane Gomez, PhD
CONTACT
Hospital de Clinicas de Porto Alegre
Other
Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial
Acronym: TAUGLIP-DM2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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