Diabetes Mellitus, Type 2
Conditions
Keywords
taurine, inflammation, glucose metabolism disorders, glycated hemoglobin, diabetes mellitus, type 2, amino acids
Brief 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.
Detailed 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.
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
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized, double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | baseline and 12 weeks | Changes from baseline glycated hemoglobin levels at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | baseline and 12 weeks | Changes from baseline fasting glucose levels at 12 weeks |
| Total serum cholesterol (CT) and fractions | 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 |
| Triglycerides serum levels | baseline and12 weeks | Changes from baseline triglycerides serum levels at 12 weeks |
| Glucose variability | for 2 weeks (10-12th week) | Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS) |
| Insulin levels | baseline and12 weeks | Changes from baseline insulin levels at 12 weeks |
| Protein creatine index | baseline and 12 weeks | Changes from baseline protein creatinine index measured in urine at 12 weeks. |
| Albuminuria | baseline and 12 weeks | Changes from baseline albuminuria levels at 12 weeks |
| Body mass index (BMI) | baseline and 4, 8, and 12 weeks | Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks. |
| Cytokine levels | baseline and 12 weeks | Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks |
Countries
Brazil
Contacts
Primary ContactBeatriz D Schaan, PhD
Backup ContactRosane Gomez, PhD
Outcome results
None listed