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Dietary Intervention in Obesity-related Glomerulopathy (ORG-VLCD-2022)

Primary Purpose

Obesity, Glomerulopathy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Optisource® Plus: Very Low Calorie Diet treatment
Hypocaloric Mediterranean Diet
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Albuminuria, Obesity, kidney function, diet, elastography, weight loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Regional Universitario de Málaga.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Very Low Calorie Diet (VLCD)

Hypocaloric Mediterranean diet

Arm Description

Patients randomized to this group will receive a VLCD, which consists of a replacement diet based on a liquid enteral formula (46% carbohydrates, 19% fat and 32% protein; 654 Kcal/day): OPTISOURCE® PLUS, taken as 3 shakes a day. In addition, participants may consume 2 pieces of fruit/day (about 250 g/day) and up to 300 g/day of non-starchy vegetables according to the list of foods that will be provided to patients; this will constitute a total daily energy intake of about 800 Kcal. In addition, protein intake (0.8 to 1.3 g/kg/day of adjusted weight) will be adjusted by adding Resource® Instant Protein individually, depending on the anthropometry and the renal function of the patients (to preserve fat free mass, whose loss has been correlated with subsequent weight recovery)

Randomized participants in this group will be recommended to follow a Mediterranean Diet, based on the use of olive oil as the main source of visible fat and regular consumption of vegetables (≥2 servings/day), fruits (≥3 servings/day), legumes (≥3 servings/week) and fish (≥3 times a week), reducing the consumption of red meat or sausages (<2 times a week) and eliminating the consumption of sugary drinks, pastries or industrial pastries. In this Mediterranean Diet, an energy restriction of 30% of the estimated energy needs (Harris-Benedict equation) will be established.

Outcomes

Primary Outcome Measures

Changes in albuminuria
Albuminuria in mg/g

Secondary Outcome Measures

Changes in glomerular filtration (kidney function)
Calculated with the formula CKD-EPI and measured in ml/min/1,73 m2
Cystatin C levels (kidney function)
Cystatin C in ng/ml
BMI (body mass index)
kg/m2
Changes in total body water (TBW)
Measured in liters
Changes in extracellular water (ECW)
Measured in liters
Changes in intracellular water (ICW)
Measured in liters
Changes in fat free mass (FFM)
Measured in kilograms
Changes in fat free mass index (FFMI)
Measured in Kg/m2
Changes in fat mass (FM)
Measured in Kilograms
Changes in fat mass index (FMI)
Measured in Kg/m2
Changes in body cell mass (BCM)
Measured in kilograms
Changes in body cell mass index (BCMI)
Measured in Kg/m2
Changes in appendicular skeletal muscle mass (ASMM)
Measured in kilograms
Changes in blood pressure
We will perform a 24-hour Ambulatory Blood Pressure Measurement (ABPM) with the SpaceLab © OnTrak meter (Spacelabs Healthcare, Washington, USA), the newest ABPM meter from this recognized manufacturer. This ABPM meter is a clinically validated device with high precision and reliability.
Changes in inflammatory biomarkers (assess kidney failure)
Measured as Fetuin A, FGF-21 and TGF-β1 by ELISA (ng/ml)
Changes in tubular and podocyte damage markers (assess kidney failure)
Measured as KIM-1 y NGAL by ELISA (ng/ml)
Changes in adipokines
Measured as leptin, adiponectin and resistin by ELISA (ng/ml)
Modifications in gut microbiota richness and diversity
Differences in α- and β-diversities between study groups will be analyzed with the open-source Quantitative Insights into Microbial Ecology (QIIME2) software, through the diversity plugin
Modifications in gut microbiota abundance and composition
Differences between the study groups at different taxa levels (phyla, family, genus and species) will be evaluated with the QIIME2 software
Modifications in gut microbiota functionality
We will evaluate the differences between sudy groups in microbial functions, analyzed with the Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt2) software, within the QIIME2 environment
Modifications in shear-wave renal elastography
Changes in kilopascals (kPA) in renal sinus

Full Information

First Posted
February 1, 2022
Last Updated
July 21, 2022
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05294770
Brief Title
Dietary Intervention in Obesity-related Glomerulopathy
Acronym
ORG-VLCD-2022
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Glomerulopathy
Keywords
Albuminuria, Obesity, kidney function, diet, elastography, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Patients will be randomized in a 1:1 ratio
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very Low Calorie Diet (VLCD)
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive a VLCD, which consists of a replacement diet based on a liquid enteral formula (46% carbohydrates, 19% fat and 32% protein; 654 Kcal/day): OPTISOURCE® PLUS, taken as 3 shakes a day. In addition, participants may consume 2 pieces of fruit/day (about 250 g/day) and up to 300 g/day of non-starchy vegetables according to the list of foods that will be provided to patients; this will constitute a total daily energy intake of about 800 Kcal. In addition, protein intake (0.8 to 1.3 g/kg/day of adjusted weight) will be adjusted by adding Resource® Instant Protein individually, depending on the anthropometry and the renal function of the patients (to preserve fat free mass, whose loss has been correlated with subsequent weight recovery)
Arm Title
Hypocaloric Mediterranean diet
Arm Type
Active Comparator
Arm Description
Randomized participants in this group will be recommended to follow a Mediterranean Diet, based on the use of olive oil as the main source of visible fat and regular consumption of vegetables (≥2 servings/day), fruits (≥3 servings/day), legumes (≥3 servings/week) and fish (≥3 times a week), reducing the consumption of red meat or sausages (<2 times a week) and eliminating the consumption of sugary drinks, pastries or industrial pastries. In this Mediterranean Diet, an energy restriction of 30% of the estimated energy needs (Harris-Benedict equation) will be established.
Intervention Type
Other
Intervention Name(s)
Optisource® Plus: Very Low Calorie Diet treatment
Intervention Description
Patients randomized to this group will receive a VLCD, which consists of a replacement diet based on a liquid enteral formula (46% carbohydrates, 19% fat and 32% protein; 654 Kcal/day): OPTISOURCE® PLUS, taken as 3 shakes a day. In addition, participants may consume 2 pieces of fruit/day (about 250 g/day) and up to 300 g/day of non-starchy vegetables according to the list of foods that will be provided to patients; this will constitute a total daily energy intake of about 800 Kcal. In addition, protein intake (0.8 to 1.3 g/kg/day of adjusted weight) will be adjusted by adding Resource® Instant Protein individually, depending on the anthropometry and the renal function of the patients (to preserve fat free mass, whose loss has been correlated with subsequent weight recovery)
Intervention Type
Other
Intervention Name(s)
Hypocaloric Mediterranean Diet
Intervention Description
Randomized participants in this group will be recommended to follow a Mediterranean Diet, based on the use of olive oil as the main source of visible fat and regular consumption of vegetables (≥2 servings/day), fruits (≥3 servings/day), legumes (≥3 servings/week) and fish (≥3 times a week), reducing the consumption of red meat or sausages (<2 times a week) and eliminating the consumption of sugary drinks, pastries or industrial pastries. In this Mediterranean Diet, an energy restriction of 30% of the estimated energy needs (Harris-Benedict equation) will be established.
Primary Outcome Measure Information:
Title
Changes in albuminuria
Description
Albuminuria in mg/g
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Changes in glomerular filtration (kidney function)
Description
Calculated with the formula CKD-EPI and measured in ml/min/1,73 m2
Time Frame
From baseline to 6 months
Title
Cystatin C levels (kidney function)
Description
Cystatin C in ng/ml
Time Frame
From baseline to 6 months
Title
BMI (body mass index)
Description
kg/m2
Time Frame
From baseline to 6 months
Title
Changes in total body water (TBW)
Description
Measured in liters
Time Frame
From baseline to 6 months
Title
Changes in extracellular water (ECW)
Description
Measured in liters
Time Frame
From baseline to 6 months
Title
Changes in intracellular water (ICW)
Description
Measured in liters
Time Frame
From baseline to 6 months
Title
Changes in fat free mass (FFM)
Description
Measured in kilograms
Time Frame
From baseline to 6 months
Title
Changes in fat free mass index (FFMI)
Description
Measured in Kg/m2
Time Frame
From baseline to 6 months
Title
Changes in fat mass (FM)
Description
Measured in Kilograms
Time Frame
From baseline to 6 months
Title
Changes in fat mass index (FMI)
Description
Measured in Kg/m2
Time Frame
From baseline to 6 months
Title
Changes in body cell mass (BCM)
Description
Measured in kilograms
Time Frame
From baseline to 6 months
Title
Changes in body cell mass index (BCMI)
Description
Measured in Kg/m2
Time Frame
From baseline to 6 months
Title
Changes in appendicular skeletal muscle mass (ASMM)
Description
Measured in kilograms
Time Frame
From baseline to 6 months
Title
Changes in blood pressure
Description
We will perform a 24-hour Ambulatory Blood Pressure Measurement (ABPM) with the SpaceLab © OnTrak meter (Spacelabs Healthcare, Washington, USA), the newest ABPM meter from this recognized manufacturer. This ABPM meter is a clinically validated device with high precision and reliability.
Time Frame
From baseline to 6 months
Title
Changes in inflammatory biomarkers (assess kidney failure)
Description
Measured as Fetuin A, FGF-21 and TGF-β1 by ELISA (ng/ml)
Time Frame
From baseline to 6 months
Title
Changes in tubular and podocyte damage markers (assess kidney failure)
Description
Measured as KIM-1 y NGAL by ELISA (ng/ml)
Time Frame
From baseline to 6 months
Title
Changes in adipokines
Description
Measured as leptin, adiponectin and resistin by ELISA (ng/ml)
Time Frame
From baseline to 6 months
Title
Modifications in gut microbiota richness and diversity
Description
Differences in α- and β-diversities between study groups will be analyzed with the open-source Quantitative Insights into Microbial Ecology (QIIME2) software, through the diversity plugin
Time Frame
From baseline to 6 months
Title
Modifications in gut microbiota abundance and composition
Description
Differences between the study groups at different taxa levels (phyla, family, genus and species) will be evaluated with the QIIME2 software
Time Frame
From baseline to 6 months
Title
Modifications in gut microbiota functionality
Description
We will evaluate the differences between sudy groups in microbial functions, analyzed with the Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt2) software, within the QIIME2 environment
Time Frame
From baseline to 6 months
Title
Modifications in shear-wave renal elastography
Description
Changes in kilopascals (kPA) in renal sinus
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Carlos Fernández García, MD, PhD.
Phone
+34 951034016
Email
josecarlosfdezgarcia@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel María Cornejo Pareja, MD, PhD.
Phone
+34 951034016
Email
isabelmaria_cornejo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos Fernández García, MD, PhD.
Organizational Affiliation
Hospital Regional Universitario de Málaga - FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga.
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Carlos Fernández García, MD, PhD
Phone
+34 951034016

12. IPD Sharing Statement

Learn more about this trial

Dietary Intervention in Obesity-related Glomerulopathy

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