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Diabetes Mellitus, Type 2Phase 2TAUGLIP-DM2NCT04874012

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

A Phase 2 study testing Active comparator Taurine in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Active comparator Taurine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
1 siteBrazil
Study dates
12 Jun 2021to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beatriz D Schaan, PhD contact

55 51 3359-8000

bschaan@hcpa.edu.br

Rosane Gomez, PhD contact

55 51 33082823

rogomez@hcpa.edu.br

Brazil1 site, 1 recruiting

  • Hospital de Clínicas

    Porto Alegre, Rio Grande do Sul, 90630090

    Beatriz D'agord Schaan, PhD, 55+513359-8000, bschaan@hcpa.edu.br

    Rosane Gomez, PhD, 55 51 33082823, rogomez@hcpa.edu.br

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Active comparator Taurine, Placebo Comparator
Keywords
taurine, inflammation, glucose metabolism disorders, glycated hemoglobin, diabetes mellitus, type 2, amino acids
Medical subject headings
Diabetes Mellitus, Type 2, Inflammation, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active comparator TaurineDrug

    Also called 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.

  • Placebo ComparatorOther

    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

Study groups in NCT04874012
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle.
Receives: Other: Placebo Comparator
TaurineActive comparatorParticipants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.
Receives: Drug: Active comparator Taurine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Changes from baseline glycated hemoglobin levels at 12 weeks

    Measured: baseline and 12 weeks

Secondary outcomes (9)

  1. Fasting glucose

    Changes from baseline fasting glucose levels at 12 weeks

    Measured: baseline and 12 weeks

  2. Insulin levels

    Changes from baseline insulin levels at 12 weeks

    Measured: baseline and12 weeks

  3. 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

    Measured: baseline and12 weeks

  4. Triglycerides serum levels

    Changes from baseline triglycerides serum levels at 12 weeks

    Measured: baseline and12 weeks

  5. Glucose variability

    Changes in glucose levels throughout the day assessed by a continuous glucose monitoring system (CGMS)

    Measured: for 2 weeks (10-12th week)

  6. Cytokine levels

    Changes from baseline TNF-α, IL-1, IL-6 levels at 12 weeks

    Measured: baseline and 12 weeks

  7. Protein creatine index

    Changes from baseline protein creatinine index measured in urine at 12 weeks.

    Measured: baseline and 12 weeks

  8. Albuminuria

    Changes from baseline albuminuria levels at 12 weeks

    Measured: baseline and 12 weeks

  9. Body mass index (BMI)

    Changes from baseline BMI calculated by weight (kg) and height (cm) at 4, 8, and 12 weeks.

    Measured: baseline and 4, 8, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start12 Jun 2021
  3. Primary completion20 Dec 2025
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874012
Sponsor's protocol ID
20200559
Acronym
TAUGLIP-DM2
Status last verified
Sep 2026
First submitted
30 Apr 2021
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28936709

  • 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.

    PubMed 22302366

  • 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.

    PubMed 12908588

  • 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.

    PubMed 23295957

  • 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.

    PubMed 21697633

  • 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.

    PubMed 29710660

  • 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.

    PubMed 33298417

  • 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.

    PubMed 33298416

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Active comparator Taurine in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beatriz D Schaan, PhD (55 51 3359-8000, bschaan@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874012, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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