The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration

Summary

In this study the investigators will examine the effects of VAT reduction by bariatric surgery on kidney hypoxia and compare kidney oxygenation before- and after surgery in both sexes using BOLD-MRI and measures of kidney hemodynamic function. Furthermore, the investigators will assess whether kidney oxygenation is reduced in obese T2D men and women versus various controls as described below. This will determine whether kidney hypoxia can be appointed as a modifiable pathogenic factor in early DKD and non-surgical interventions targeting kidney hypoxia can be designed to slow DKD progression.

Eligibility

Group 1: T2DM patients with obesity and hyperfiltration

Inclusion criteria:

* 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 ≥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

Exclusion criteria:

* 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 2: Non-diabetic lean controls

Inclusion criteria:

* Caucasian; male of female aged ≥18 years and \<40 years. Females must be pre-menopausal
* 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

Exclusion criteria:

* Macro-albuminuria (defined as UACR\>30 mg/mmol)
* 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 renin-angiotensin-system blockers, sodium-glucose transporter-2 inhibitors, GLP-1 receptor agonists, 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

Conditions3

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