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临床试验/NCT07072949
NCT07072949已完成1 期

The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial

University of Banja Luka2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Change in fasting plasma glucose (FPG) from baseline to week 4

研究概览

简要总结

A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 25 years
  • Clinical diagnosis of type 2 diabetes mellitus (T2DM) within the past 12 months
  • Body mass index (BMI) ≥ 25 kg/m²
  • Stable metformin therapy (1000-2000 mg daily in divided doses)
  • No use of probiotics, antibiotics, vitamins, or minerals in the past 30 days

排除标准

  • Diagnosis of type 1 diabetes mellitus
  • History or diagnosis of gastrointestinal diseases
  • Chronic kidney disease
  • Valvular heart disease
  • Pregnancy
  • Presence of any acute infection

结局指标

主要结局

Change in fasting plasma glucose (FPG) from baseline to week 4

时间窗: Baseline and after 4 weeks of intervention

Fasting plasma glucose concentration will be measured in mmol/L to assess changes in glycemic control following treatment in each group.

Change in postprandial glucose (PPG) from baseline to week 4

时间窗: Baseline and after 4 weeks of intervention

Postprandial plasma glucose concentration will be measured 2 hours after a standardized meal to evaluate treatment efficacy. Unit of measure: mmol/L

Change in hemoglobin A1c (HbA1c) from baseline to week 4

时间窗: Baseline and after 4 weeks of intervention

Glycated hemoglobin (HbA1c) will be measured to assess average blood glucose levels over the preceding 4 weeks. Unit of measure: Percent (%)

Percentage of participants achieving HbA1c < 7.0% at week 4

时间窗: After 4 weeks of intervention

Proportion of participants in each group achieving HbA1c values below 7.0%, indicating improved glycemic control. Unit of measure: Percentage of participants (%)

次要结局

  • Change in total cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
  • Change in LDL cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
  • Change in HDL cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
  • Change in triglycerides from baseline to week 4(Baseline and after 4 weeks of intervention)
  • Change in C-Reactive Protein (CRP) from baseline to week 4(Baseline and after 4 weeks of intervention)

研究者

发起方
University of Banja Luka
申办方类型
Other
责任方
Sponsor

研究点 (2)

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