Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes (TAUGLIP-DM2)

February 28, 2024 updated by: Hospital de Clinicas de Porto Alegre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630090
        • Recruiting
        • Hospital de Clinicas
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
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
Active Comparator: Taurine
Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.
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 Names:
  • Taurine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Beatriz D Schaan, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200559

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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