Clinical trial NCT05294770: Dietary Intervention in Obesity-related Glomerulopathy
Official title: Efficacy of a Very Low Calorie Diet or a Hypocaloric Mediterranean Diet on Albuminuria and Renal Function in Patients With Obesity-related Glomerulopathy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Glomerulopathy
Keywords: Albuminuria
Obesity
kidney function
diet
elastography
weight loss
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity-related glomerulopathy (ORG) is a silent comorbidity associated with obesity whose incidence is increasing in parallel to the obesity epidemic. ORG is associated with serious health consequences including chronic kidney disease, end-stage renal disease, and increased mortality. Unfortunately, ORG has an absence of targeted therapy (except for the use of drugs blocking the renin-angiotensin system), and therefore the prognosis of this disease may be seriously compromised. Some previous studies have shown that weight loss could be effective to decrease albuminuria and reduce the declining in kidney function in subject with obesity. In line with this, in this study the investigators will evaluate the efficacy of two different dietary strategies for ORG, given the current lack of therapies for this condition. Thus, the investigators will conduct an open-label randomized controlled trial comparing a hypocaloric Mediterranean diet with a very-low calorie diet (VLCD), evaluating the efficacy on albuminuria reduction and changes in renal function. Also, the investigators will assess changes on body composition, blood pressure, markers of renal damage and inflammation, gut microbiota, and on renal ultrasound elastography.

Detailed description: Our hypothesis is that a dietary strategy based on a very low calorie diet (VLCD) will produce a greater reduction in albuminuria than a hypocaloric Mediterranean diet in subjects with ORG. This improvement will be achieved through weight loss and changes in body composition, the reduction of blood pressure, the decrease in inflammatory, tubular and podocyte damage markers, modifications in adipokine concentrations, changes in the intestinal microbiota and in renal elastography.

The main objective of this clinical trial is to evaluate which dietary strategy (VLCD diet or Mediterranean hypocaloric diet) is more effective in reducing albuminuria and preserving renal function in patients with ORG.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 kg/m2
* Albuminuria ≥ 150 mg/g
* eGFR ≥ 30 ml/min/1,73 m²
* Informed consent signed
* All patients should receive a stable dose of ACE inhibitors or ARBs for at least 4 weeks prior to randomization. Before randomization; A stable dose will be considered to be the maximum dose indicated in the drug's SmPC or a dose that is not associated with unacceptable side effects in the patient.

Exclusion Criteria:

* Previous diagnosis of diabetes mellitus (defined by HbA1c ≥ 6.5% or baseline blood glucose ≥126 mg / dl or blood glucose 2 hours after oral glucose overload ≥200 mg / dl).
* Treatment with oral hypoglycemic agents, insulin or GLP-1 receptor agonists.
* Active cancer
* History of liver tumor or acute or chronic liver diseases with impaired liver function: total bilirubin levels\> 2.0 mg / dL or AST levels three times higher than the upper limit of normal.
* Established cardiovascular disease (stroke, acute myocardial infarction, cardiac revascularization).
* Uncontrolled hypertension (systolic blood pressure\> 180 mmHg or diastolic blood pressure\> 110 mmHg) despite adequate antihypertensive treatment.
* Infection with HIV, HBV, HCV or other infection that can lead to secondary glomerular disease
* Suspicion of primary glomerulopathy (except GAO).
* Evidence of drug or alcohol abuse.
* Serious underlying conditions that, in the opinion of the investigators, could affect the patient's ability to participate in the study.
* Limited life expectancy (\<12 months).
* Pregnancy or breastfeeding.
* Impossibility of following the indicated diet.
* Inability to follow scheduled visits.

Primary outcomes:
measure: Changes in albuminuria
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Changes in glomerular filtration (kidney function)
timeFrame: From baseline to 6 months
measure: Cystatin C levels (kidney function)
timeFrame: From baseline to 6 months
measure: BMI (body mass index)
timeFrame: From baseline to 6 months
measure: Changes in total body water (TBW)
timeFrame: From baseline to 6 months
measure: Changes in extracellular water (ECW)
timeFrame: From baseline to 6 months
measure: Changes in intracellular water (ICW)
timeFrame: From baseline to 6 months
measure: Changes in fat free mass (FFM)
timeFrame: From baseline to 6 months
measure: Changes in fat free mass index (FFMI)
timeFrame: From baseline to 6 months
measure: Changes in fat mass (FM)
timeFrame: From baseline to 6 months
measure: Changes in fat mass index (FMI)
timeFrame: From baseline to 6 months
measure: Changes in body cell mass (BCM)
timeFrame: From baseline to 6 months
measure: Changes in body cell mass index (BCMI)
timeFrame: From baseline to 6 months
measure: Changes in appendicular skeletal muscle mass (ASMM)
timeFrame: From baseline to 6 months
measure: Changes in blood pressure
timeFrame: From baseline to 6 months
measure: Changes in inflammatory biomarkers (assess kidney failure)
timeFrame: From baseline to 6 months
measure: Changes in tubular and podocyte damage markers (assess kidney failure)
timeFrame: From baseline to 6 months
measure: Changes in adipokines
timeFrame: From baseline to 6 months
measure: Modifications in gut microbiota richness and diversity
timeFrame: From baseline to 6 months
measure: Modifications in gut microbiota abundance and composition
timeFrame: From baseline to 6 months
measure: Modifications in gut microbiota functionality
timeFrame: From baseline to 6 months
measure: Modifications in shear-wave renal elastography
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga.
Study officials:
affiliation: Hospital Regional Universitario de Málaga - FIMABIS
name: José Carlos Fernández García, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: