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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Netherlands
VU University Medical Center
RECRUITING
Amsterdam
Contact Information
Primary
D.H. van Raalte, MD
d.vanraalte@amsterdamumc.nl
+31 204442974
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 100
Treatments
Obese patients
Obese patients with T2D and hyperfiltration that will undergo bariatric surgery
Healthy controls
Healthy, lean controls with BMI 20-25
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Kidney Foundation, Dutch Diabetes Research Foundation
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov