Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals with Type 2 Diabetes

Last updated: October 7, 2024
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Active comparator Taurine

Placebo Comparator

Clinical Study ID

NCT04874012
20200559
  • Ages 30-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Active comparator Taurine
Phase: 2
Study Start date:
June 12, 2021
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Hospital de Clínicas

    Porto Alegre, Rio Grande do Sul 90630090
    Brazil

    Active - Recruiting

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