EUCTR2014-003923-23-GB进行中（未招募）1 期
GLP-1 Receptor Agonist interVentIon for poor responders afTer bariAtric Surgery: The GRAVITAS trial - GRAVITAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male or female
- •Aged between 18-70 years
- •=12 months after gastric bypass or sleeve gastrectomy bariatric surgery
- •Diagnosed with Type 2 diabetes mellitus according to WHO 2006 and 2011 criteria
- •HbA1c >6.5% (>48 mmol/mol) on screening
- •On Metformin ± long acting insulin
- •Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Diagnosed with Type 1 diabetes mellitus
- •Anatomical or endocrinological pathology causing poor weight loss or weight regain
- •Screening calcitonin of 50 ng/L or above
- •Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- •Personal history of non-familial medullary thyroid carcinoma
- •History of acute or chronic pancreatitis
- •Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
- •Estimated glomerular filtration rate (eGFR) <30 ml/min • 1.73 m2).
- •Current pregnancy.
- •Inability to maintain adequate contraception.
研究者
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