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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Active comparator Taurine	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	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

Timeline

• Start date: 2021-06-12
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2021-05-05
• Last updated: 2025-09-19

Locations

1 site across 1 country: Brazil