Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3883
Source ID: NCT04874012
Associated Drug: Active Comparator Taurine
Title: Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals with Type 2 Diabetes
Acronym: TAUGLIP-DM2
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Active comparator Taurine|OTHER: Placebo Comparator
Outcome Measures: 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|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
Sponsor/Collaborators: Sponsor: Hospital de Clinicas de Porto Alegre
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 94
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-06-12
Completion Date: 2025-03-01
Results First Posted:
Last Update Posted: 2024-10-08
Locations: Hospital de Clínicas, Porto Alegre, Rio Grande do Sul, 90630090, Brazil
URL: https://clinicaltrials.gov/show/NCT04874012