Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.
详细描述
This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic;
- •Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4.
排除标准
- •Except for the use of insulin, no other treatments for T1D will be permitted.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Conventional Therapy / Butyrate
Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
干预措施: BKR-017 (Drug)
结局指标
主要结局
Insulin sensitivity
时间窗: (Day 0) to Day 28 and Day 56
Change in Insulin sensitivity
次要结局
- Glucose Variability and Triglycerides((Day 0) to Day 28 and Day 56)