Examining how bariatric surgery affects kidney oxygen levels in obese adults with type 2 diabetes
The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration
Amsterdam UMC, location VUmc · NCT06284785
This study is testing how bariatric surgery affects oxygen levels in the kidneys of obese adults with type 2 diabetes to see if it can help improve their kidney health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT06284785 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of bariatric surgery on kidney oxygenation in obese adults suffering from type 2 diabetes and hyperfiltration. Using BOLD-MRI and kidney hemodynamic function measures, the study compares kidney oxygen levels before and after surgery in both men and women. The goal is to determine if kidney hypoxia can be identified as a modifiable factor in the progression of diabetic kidney disease (DKD) and to explore potential non-surgical interventions targeting this issue. The study also aims to assess differences in kidney oxygenation between obese T2D patients and various control groups.
Who should consider this trial
Good fit: Ideal candidates include Caucasian men and women aged 18-55 with obesity, type 2 diabetes, and hyperfiltration scheduled for gastric bypass or sleeve surgery.
Not a fit: Patients with type 1 diabetes, post-menopausal women, or those with recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for diabetic kidney disease by targeting kidney hypoxia.
How similar studies have performed: While some studies have shown improvements in kidney outcomes following bariatric surgery, this specific approach focusing on kidney hypoxia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam, Noord-Holland
- VU University Medical Center — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Daniel H van Raalte, MD — AmsterdamUMC
- Study coordinator: D.H. van Raalte, MD
- Email: d.vanraalte@amsterdamumc.nl
- Phone: +31 204442974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Hypoxia, Diabetes Mellitus, Type 2, Obesity, Bariatric surgery