NL-OMON53673招募中不适用
The effects of bariatric surgery on kidney oxygenation in obese adults with type 2 diabetes and hyperfiltration - ECSTASY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Group 1: Patients with obesity and hyperfiltration • ; man or women aged >=18
- •years and <70 years. • BMI >=35 • eGFR>90 ml/min calculated as by CKD-EPI •
- •Provision of signed and dated, written informed consent prior to any study
- •specific procedures • Hypertension should be controlled, i.e., <= 155/95 mmHg. •
- •Scheduled for gastric bypass or gastric sleeve Group 2: Non-diabetic lean
- •controls • male of female aged >=18 years and <40 years. • Provision of signed
- •and dated, written informed consent prior to any study specific procedures. •
- •Normal glucose tolerance confirmed by HbA1c • No hypertension • BMI >=18,5 and
- •<25 kg/m² Group 3: T2DM controls with overweight and eGFR 60-90 ml/min •
- •Caucasian; man or women aged >=18 years and <55 years. Females must be
- •pre-menopausal • Type 2 diabetes mellitus or pre-diabetes with HbA1c >=45mmol/
- •mol and <10% (<94mmol/mol) • BMI >=25 • eGFR 60-90 ml/min calculated as by
- •CKD-EPI • Hypertension should be controlled, i.e., <= 155/95 mmHg. Group 4:
- •Non-diabetic controls with overweight and eGFR 60-90 ml/min • Caucasian; male
- •of female aged >=18 years and <55 years. Females must be pre-menopausal • Normal
- •glucose tolerance confirmed by HbA1c • eGFR 60-90 ml/min calculated as by
- •CKD-EPI • Hypertension should be controlled, i.e., <= 155/95 mmHg. • BMI >=25
排除标准
- •Group 1 • Diagnosis of type 1 diabetes mellitus • Cardiovascular disease event
- •in the last 6 months prior to enrollment as assessed by the investigator,
- •including: myocardial infarction, cardiac surgery or revascularization
- •(CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or
- •significant cerebrovascular disease, unstable or previously undiagnosed
- •arrhythmia. • Chronic use of sodium-glucose transporter-2 inhibitors, oral
- •glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune
- •suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants
- •(TCAs), diuretics, or monoamine oxidase inhibitors. • Current urinary tract
- •infection or active nephritis • History of allergy/hypersensitivity to any of
- •the test agents • Contra-indication for MRI • Any other condition that prevents
- •participation as judged by investigator. Group 2: Non-diabetic lean controls
- •Macro-albuminuria (defined as UACR>30 mg/mmol) • . •
- •Cardiovascular disease event in the last 6 months prior to enrollment as
- •assessed by the investigator, including: myocardial infarction, cardiac surgery
- •or revascularization (CABG/PTCA), unstable angina, heart failure, transient
- •ischemic attack (TIA) or significant cerebrovascular disease, unstable or
- •previously undiagnosed arrhythmia. • Chronic use of renin-angiotensin-system
- •blockers, sodium-glucose transporter-2 inhibitors, DPP-4 inhibitors, oral
- •glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune
- •suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants
- •(TCAs), diuretics ormonoamine oxidase inhibitors. • Current urinary tract
- •infection or active nephritis • History of allergy/hypersensitivity to any of
- •the test agents • Contra-indication for MRI Group 3: T2DM controls with
- •overweight and eGFR 60-90 ml/min • Diagnosis of type 1
- •diabetes mellitus • Post-menopausal females (defined as no menses >1 year and
- •follicle stimulating hormone (FSH) >31 U/L) • Cardiovascular disease event in
- •the last 6 months prior to enrollment as assessed by the investigator,
- •including: myocardial infarction, cardiac surgery or revascularization
- •(CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or
- •significant cerebrovascular disease, unstable or previously undiagnosed
- •arrhythmia. • Chronic use of sodium-glucose transporter-2 inhibitors, oral
- •glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune
- •suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants
- •(TCAs), diuretics, or monoamine oxidase inhibitors. • Current urinary tract
- •infection or active nephritis • History of allergy/hypersensitivity to any of
- •the test agents • Contra-indication for MRI • Any other condition that prevents
- •participation as judged by investigator. Group 4: Non-diabetic controls with
- •overweight and eGFR 60-90 ml/min • Post-menopausal females (defined as no
- •menses >1 year and follicle stimulating hormone (FSH) >31 U/L) • Cardiovascular
- •disease event in the last 6 months prior to enrollment as assessed by the
- •investigator, including: myocardial infarction, cardiac surgery or
- •revascularization (CABG/PTCA), unstable angina, heart failure, transient
- •ischemic attack (TIA) or significant cerebrovascular disease, unstable or
- •previously u
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