NCT05795972招募中不适用
Efficacy Evaluation of Inulin Supplementation on Metabolic Control and Akkermansia Muciniphila Levels in Patients With Type 1 Diabetes: a Pilot Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- glycemic control
研究概览
简要总结
The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo.
Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T1D, diagnosed before 35 years of age will be enrolled
排除标准
- •advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
- •BMI> 30 kg / m2.
结局指标
主要结局
glycemic control
时间窗: 3 months
represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).
次要结局
- akkermania levels(3 months)
研究者
OJETTI VERONICA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (2)
Loading locations...
相似试验
撤回
1 期
A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection TherapyDiabetes Mellitus, Type 1NCT02623452Eli Lilly and Company
已完成
1 期
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection TherapyDiabetes Mellitus, Type 1NCT02703350Eli Lilly and Company30
已完成
3 期
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.Diabetes Mellitus, Type 1NCT00424437Pfizer320
已完成
3 期
Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 DiabetesDiabetes Mellitus, Type 1NCT00424333Pfizer320
已完成
不适用
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and GlargineDiabetes Mellitus Type 1NCT00468754Hoffmann-La Roche50