The effects of bariatric surgery on kidney oxygenation in obese adults with type 2 diabetes and hyperfiltratio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in kidney oxygenation in obese, hyperfiltering adults with T2D after<br /><br>bariatric surgery for men and women separately using BOLD-MRI</p><br>

Secondary Outcome Measures