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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-80
SponsorHospital de Clinicas de Porto Alegre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo Comparator

    Other intervention

    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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: TaurineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Changes from baseline glycated hemoglobin levels at 12 weeks

Time frame
baseline and 12 weeks

Secondary outcomes

1

Fasting glucose

Changes from baseline fasting glucose levels at 12 weeks

Time frame
baseline and 12 weeks
2

Insulin levels

Changes from baseline insulin levels at 12 weeks

Time frame
baseline and12 weeks
3

Total serum cholesterol (CT) and fractions

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
4

Triglycerides serum levels

Changes from baseline triglycerides serum levels at 12 weeks

Time frame
baseline and12 weeks

Other outcomes

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