Diabetes Mellitus, Type 2 Clinical Trial
— TAUGLIP-DM2Official 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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |