RecruitingPhase 2NCT04874012

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

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

94 participants

Start Date

Jun 12, 2021

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial tests whether taurine — a natural amino acid found in the body and in some foods — can improve blood sugar control, cholesterol levels, and inflammation in people with type 2 diabetes whose blood sugar is not well controlled. **You may be eligible if...** - You are over 30 years old (male or female) with a type 2 diabetes diagnosis for at least 6 months - Your HbA1c (a measure of average blood sugar) is between 7.5% and 10.5% - Your BMI is 18.5 or higher and your weight has been stable for the past 3 months **You may NOT be eligible if...** - You are currently taking herbal supplements, antioxidants, or multivitamins - You are pregnant or breastfeeding - You have severe kidney disease - You have had a heart attack in the past 6 months - You have an active cancer diagnosis - You regularly take steroid (glucocorticoid) medications - You have had bariatric (weight loss) surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGActive 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.

OTHERPlacebo 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

Locations(1)

Hospital de Clínicas

Porto Alegre, Rio Grande do Sul, Brazil

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NCT04874012

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