Clinical trial

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

Name

20200559

Description

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.

Trial arms

Trial start

2021-06-12

Estimated PCD

2024-08-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Taurine

Other names:

Taurine

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

Arms:

Placebo

Size

Primary endpoint

HbA1c

baseline and 12 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The generation of the sequence of numbers will be done by a blinded researcher, after selecting the participant by the inclusion and exclusion criteria. The concealment of allocation will be implemented by a central randomization routine, conducted by researchers with access to the list and by the researcher responsible for requesting the code for placement of individuals in the study.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 94, 'type': 'ESTIMATED'}}

Updated at

2024-03-01

1 organization

1 product

2 indications

Organization

Hospital de Clinicas de Porto Alegre

Product

Taurine

Indication

Diabetes Mellitus

Indication

Type 2