Status:
UNKNOWN
Dietary Intervention in Obesity-related Glomerulopathy
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions:
Obesity
Glomerulopathy
Eligibility:
All Genders
18-70 years
Phase:
NA
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 consequenc...
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 impro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05294770
Start Date
July 18 2022
End Date
September 1 2024
Last Update
July 25 2022
Active Locations (1)
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1
Hospital Regional Universitario de Málaga.
Málaga, Spain, 29009