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

NCT04874012 | Recruiting Phase 2

• 1 other identifier: 20200559
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

taurine; inflammation; glucose metabolism disorders; glycated hemoglobin; diabetes mellitus, type 2; amino acids

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Changes from baseline glycated hemoglobin levels at 12 weeks

  baseline and 12 weeks

Secondary Outcomes (9)

• Fasting glucose

  baseline and 12 weeks

• Insulin levels

  baseline and12 weeks

• Total serum cholesterol (CT) and fractions

  baseline and12 weeks

• Triglycerides serum levels

  baseline and12 weeks

• Glucose variability

  for 2 weeks (10-12th week)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Taurine

ACTIVE COMPARATOR

Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.

Drug: Active comparator Taurine

Interventions

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.

Also known as: Taurine

Taurine

Placebo Comparator OTHER

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

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas

Porto Alegre, Rio Grande do Sul, 90630090, Brazil

RECRUITING

Related Publications (8)

• 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.

  PMID: 28936709 BACKGROUND

• 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.

  PMID: 22302366 BACKGROUND

• 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.

  PMID: 12908588 BACKGROUND

• 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.

  PMID: 23295957 BACKGROUND

• 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.

  PMID: 21697633 BACKGROUND

• 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.

  PMID: 29710660 BACKGROUND

• 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.

  PMID: 33298417 BACKGROUND

• 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.

  PMID: 33298416 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Glucose Metabolism Disorders

Interventions

Taurine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Beatriz D Schaan, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz D Schaan, PhD

CONTACT

55 51 3359-8000; bschaan@hcpa.edu.br

Rosane Gomez, PhD

CONTACT

55 51 33082823; rogomez@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: June 12, 2021
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)