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

NCT06284785 | Recruiting DMC

• 1 other identifier: 2023.0121
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Hypoxia; Diabetes Mellitus, Type 2

Keywords

Obesity; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Difference in kidney oxygenation before and after bariatric surgery

  BOLD-MRI

  1 year

Secondary Outcomes (2)

• Difference in kidney oxygenation between men and women

  baseline, 1 year

• Difference in kidney oxygenation between obese, hyperfiltering men and women with T2D versus non-diabetic lean controls

  Baseline

Study Arms (2)

Obese patients

Obese patients with T2D and hyperfiltration that will undergo bariatric surgery

Procedure: Bariatric surgery

Healthy controls

Healthy, lean controls with BMI 20-25

Interventions

Bariatric surgery PROCEDURE

Patients included in our obese patient group are all scheduled to undergo bariatric surgery

Obese patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in our patient group will be selected from the Bariatric outpatient clinic. Participants in our control group will be selected from the student campus

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Macro-albuminuria (defined as UACR\>30 mg/mmol)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Kidney Foundation: collaborator
• Dutch Diabetes Research Foundation: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Daniel H van Raalte, MD

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D.H. van Raalte, MD

CONTACT

+31 204442974; d.vanraalte@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Daniel H. van Raalte

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: February 29, 2024
• Study Start: August 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)