Complementary Effects of New Diabetes Medications on Adrenal Function and Intestinal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Urinary aldosterone at 3 months
研究概览
简要总结
The primary aim of this observational study is to describe the effects of glucagon-like peptide-1 (GLP-1) receptor agonists and Sodium-Glucose Co-transporter 2 inhibitors ( SGLT-2 inhibitors) on adrenal function. Secondary endpoint is change in intestinal microbiota.
详细描述
This is an observational study conducted in patients with type 2 diabetes starting treatment with either GLP-1 receptor agonist or sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Planned study cohort consists of 60 patients: 30 patients starting GLP-1 receptor agonist treatment and 30 patients starting SGLT-2 inhibitor treatment. All patients must have metformin as background therapy. All other diabetes medications are allowed.
Patients are tested before starting treatment, at 1 month (stool sample only), 3 months and 12 months after starting treatment. The primary endpoint is change in overnight urinary aldosterone corrected for creatinine.
Secondary endpoint is change in intestinal microbiota composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 years
- •Type 2 diabetes
- •HbA1c < 10%
- •Daily dose of metformin 1,5 g or more.
- •No change in diabetes treatment at least 90 days before starting the study.
- •Never used SGLT-2 inhibitors or/and GLP-1 receptor agonist.
- •Tested negative to glutamic acid decarboxylase 65 autoantibodies.
排除标准
- •Pregnancy and lactation.
- •Use of systemic antibiotic treatment < 60 days before starting the study.
- •Use of spironolactone < 60 days before starting the study.
- •Use of oral contraceptives or hormonal replacement therapy.
- •Use of immunosuppressive drug
- •Heart failure New York Heart Association III-IV
- •Severe liver disease.
- •Malignant disease.
研究组 & 干预措施
GLP-1 receptor agonist treatment
Patients starting treatment with any molecule belonging to the class of GLP-1 receptor agonist.
干预措施: GLP-1 receptor agonist (Drug)
SGLT-2 inhibitor treatment
Patients starting treatment with any molecule belonging to the class of SGLT-2 inhibitors.
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Urinary aldosterone at 3 months
时间窗: 3 months
Overnight urinary aldosterone compared to pretreatment level.
次要结局
- Change in gastrointestinal microbiota.(At 1 month after starting treatment, at 3 months and 12 months.)
- Urinary aldosterone at 12 months(12 months)
研究者
Vallo Volke
Professor
University of Tartu