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NCT Number: NCT04874012

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active comparator Taurine

Drug

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

Placebo Comparator

Other

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

Primary outcomes

  1. HbA1c

    Time frame: baseline and 12 weeks

    Changes from baseline glycated hemoglobin levels at 12 weeks

Secondary outcomes

  1. Fasting glucose

    Time frame: baseline and 12 weeks

    Changes from baseline fasting glucose levels at 12 weeks

  2. Insulin levels

    Time frame: baseline and12 weeks

    Changes from baseline insulin levels at 12 weeks

  3. Total serum cholesterol (CT) and fractions

    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

  4. Triglycerides serum levels

    Time frame: baseline and12 weeks

    Changes from baseline triglycerides serum levels at 12 weeks

  5. Glucose variability

    Time frame: for 2 weeks (10-12th week)

    Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)

  6. Cytokine levels

    Time frame: baseline and 12 weeks

    Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks

  7. Protein creatine index

    Time frame: baseline and 12 weeks

    Changes from baseline protein creatinine index measured in urine at 12 weeks.

  8. Albuminuria

    Time frame: baseline and 12 weeks

    Changes from baseline albuminuria levels at 12 weeks

  9. Body mass index (BMI)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz D Schaan, PhD

CONTACT

[email protected]

55 51 3359-8000

Rosane Gomez, PhD

CONTACT

[email protected]

55 51 33082823

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial

Acronym: TAUGLIP-DM2

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 5, 2021
Registry last updated
Sep 19, 2025

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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