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Clinical Trial Details

Trial ID: L3120
Source ID: NCT06351566
Associated Drug: Vitamin D3
Title: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Vitamin D3|DIETARY_SUPPLEMENT: Prebiotics|DIETARY_SUPPLEMENT: Vitamin D3 placebo|DIETARY_SUPPLEMENT: Prebiotics placebo
Outcome Measures: Primary: Glycated hemoglobin (HbA1c), Concentration of HbA1c, measured in the percentage of hemoglobin, 6 months|Concentration of blood lipids, Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L, 6 months|Metagenomic analysis of the gut microbiota, The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing, 6 months | Secondary: Concentration of fasting glucose, Concentration of fasting glucose, measured in mmol/L, 6 months|Concentration of fasting insulin, Concentration of fasting insulin, measured in milli-International unit/L, 6 months|Systolic and diastolic blood pressure, The level of systolic blood pressure and diastolic blood pressure, measured in mmHg, 6 months|Estimated glomerular filtration rate (eGFR), Calculating the level of eGFR using Chronic Kidney Disease Epidemiology Collaboration equation, 6 months|Concentration of C-reactive protein (CRP), Concentration of CRP, measured in mg/dL, 6 months|Concentration of procalcitonin, Concentration of procalcitonin, measured in pg/mL, 6 months|Concentration of interleukin-6 (IL-6), Concentration of IL-6, measured in pg/mL, 6 months|Concentration of serum 25(OH)D, Concentration of serum 25(OH)D concentrations, measured in nmol/L, 6 months|Body weight, Weight in kilograms, 6 months|Waist circumference, Waist circumference in centimeters, 6 months|Hip circumference, Hip circumference in centimeters, 6 months
Sponsor/Collaborators: Sponsor: Huazhong University of Science and Technology
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-25
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2024-06-17
Locations: Bao'an Center Hosipital of Shenzhen, Shenzhen, Guangdong, China|School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
URL: https://clinicaltrials.gov/show/NCT06351566