Dietary Intervention in Obesity-related Glomerulopathy

NCT05294770 | Unknown

• 1 other identifier: ORG-VLCD-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Glomerulopathy

Keywords

Albuminuria; Obesity; kidney function; diet; elastography; weight loss

Outcome Measures

Primary Outcomes (1)

• Changes in albuminuria

  Albuminuria in mg/g

  From baseline to 6 months

Secondary Outcomes (21)

• Changes in glomerular filtration (kidney function)

  From baseline to 6 months

• Cystatin C levels (kidney function)

  From baseline to 6 months

• BMI (body mass index)

  From baseline to 6 months

• Changes in total body water (TBW)

  From baseline to 6 months

• Changes in extracellular water (ECW)

  From baseline to 6 months

Study Arms (2)

Very Low Calorie Diet (VLCD)

EXPERIMENTAL

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)

Other: Optisource® Plus: Very Low Calorie Diet treatment

Hypocaloric Mediterranean diet

ACTIVE COMPARATOR

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.

Other: Hypocaloric Mediterranean Diet

Interventions

Optisource® Plus: Very Low Calorie Diet treatment OTHER

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)

Very Low Calorie Diet (VLCD)

Hypocaloric Mediterranean Diet OTHER

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.

Hypocaloric Mediterranean diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga.

Málaga, 29009, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Albuminuria; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Body Weight Changes

Study Officials

• José Carlos Fernández García, MD, PhD.

  Hospital Regional Universitario de Málaga - FIMABIS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Carlos Fernández García, MD, PhD.

CONTACT

+34 951034016; josecarlosfdezgarcia@hotmail.com

Isabel María Cornejo Pareja, MD, PhD.

CONTACT

+34 951034016; isabelmaria_cornejo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomized in a 1:1 ratio
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 24, 2022
• Study Start: July 18, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: July 25, 2022

Record last verified: 2022-01

Locations

ES (1)