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

Diabetes Mellitus, Type 2 Clinical Trial

— TAUGLIP-DM2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874012
• Other study ID #: 20200559
• Status: Recruiting
• Phase: Phase 2
• Start date: June 12, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Beatriz D Schaan, PhD
• Phone: 55 51 3359-8000
• Email: bschaan[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Other:
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

American Diabetes Association. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S53-S72. doi: 10.2337/dc21-S005. — View Citation

American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006. — View Citation

Caletti G, Herrmann AP, Pulcinelli RR, Steffens L, Moras AM, Vianna P, Chies JAB, Moura DJ, Barros HMT, Gomez R. Taurine counteracts the neurotoxic effects of streptozotocin-induced diabetes in rats. Amino Acids. 2018 Jan;50(1):95-104. doi: 10.1007/s00726-017-2495-1. Epub 2017 Sep 21. — View Citation

Caletti G, Olguins DB, Pedrollo EF, Barros HM, Gomez R. Antidepressant effect of taurine in diabetic rats. Amino Acids. 2012 Oct;43(4):1525-33. doi: 10.1007/s00726-012-1226-x. — View Citation

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. — View Citation

Chauncey KB, Tenner TE Jr, Lombardini JB, Jones BG, Brooks ML, Warner RD, Davis RL, Ragain RM. The effect of taurine supplementation on patients with type 2 diabetes mellitus. Adv Exp Med Biol. 2003;526:91-6. doi: 10.1007/978-1-4615-0077-3_12. No abstract available. — View Citation

Fukuda N, Yoshitama A, Sugita S, Fujita M, Murakami S. Dietary taurine reduces hepatic secretion of cholesteryl ester and enhances fatty acid oxidation in rats fed a high-cholesterol diet. J Nutr Sci Vitaminol (Tokyo). 2011;57(2):144-9. doi: 10.3177/jnsv.57.144. — View Citation

Gomez R, Caletti G, Arbo BD, Hoefel AL, Schneider R Jr, Hansen AW, Pulcinelli RR, Freese L, Bandiera S, Kucharski LC, Barros HMT. Acute intraperitoneal administration of taurine decreases the glycemia and reduces food intake in type 1 diabetic rats. Biomed Pharmacother. 2018 Jul;103:1028-1034. doi: 10.1016/j.biopha.2018.04.131. Epub 2018 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Changes from baseline glycated hemoglobin levels at 12 weeks	baseline and 12 weeks
Secondary	Fasting glucose	Changes from baseline fasting glucose levels at 12 weeks	baseline and 12 weeks
Secondary	Insulin levels	Changes from baseline insulin levels at 12 weeks	baseline and12 weeks
Secondary	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
Secondary	Triglycerides serum levels	Changes from baseline triglycerides serum levels at 12 weeks	baseline and12 weeks
Secondary	Glucose variability	Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)	for 2 weeks (10-12th week)
Secondary	Cytokine levels	Changes from baseline TNF-a, IL-1, IL-6 levels at 12 weeks	baseline and 12 weeks
Secondary	Protein creatine index	Changes from baseline protein creatinine index measured in urine at 12 weeks.	baseline and 12 weeks
Secondary	Albuminuria	Changes from baseline albuminuria levels at 12 weeks	baseline and 12 weeks
Secondary	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