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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Active comparator Taurine
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle. | Other: Placebo Comparator<br>* 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<br>|
| Active Comparator: Taurine<br>Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks. | Drug: Active comparator Taurine<br>* 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.<br>* Other names: Taurine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Changes from baseline glycated hemoglobin levels at 12 weeks | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Changes from baseline fasting glucose levels at 12 weeks | baseline and 12 weeks | 
| Insulin levels | Changes from baseline insulin levels at 12 weeks | baseline and12 weeks | 
| 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 | baseline and12 weeks | 
| Triglycerides serum levels | Changes from baseline triglycerides serum levels at 12 weeks | baseline and12 weeks | 
| Glucose variability | Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS) | for 2 weeks (10-12th week) | 
| Cytokine levels | Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks | baseline and 12 weeks | 
| Protein creatine index | Changes from baseline protein creatinine index measured in urine at 12 weeks. | baseline and 12 weeks | 
| Albuminuria | Changes from baseline albuminuria levels at 12 weeks | baseline and 12 weeks | 
| Body mass index (BMI) | Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks. | baseline and 4, 8, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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taurine, inflammation, glucose metabolism disorders, glycated hemoglobin, diabetes mellitus, type 2, amino acids