Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in albuminuria | Albuminuria in mg/g | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glomerular filtration (kidney function) | Calculated with the formula CKD-EPI and measured in ml/min/1,73 m2 | From baseline to 6 months |
| Cystatin C levels (kidney function) | Cystatin C in ng/ml |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| José Carlos Fernández García, MD, PhD. | Hospital Regional Universitario de Málaga - FIMABIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario de Málaga. | Recruiting | Málaga | 29009 | Spain |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000419 | Albuminuria |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be randomized in a 1:1 ratio
Not provided
|
| 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. |
|
| From baseline to 6 months |
| BMI (body mass index) | kg/m2 | From baseline to 6 months |
| Changes in total body water (TBW) | Measured in liters | From baseline to 6 months |
| Changes in extracellular water (ECW) | Measured in liters | From baseline to 6 months |
| Changes in intracellular water (ICW) | Measured in liters | From baseline to 6 months |
| Changes in fat free mass (FFM) | Measured in kilograms | From baseline to 6 months |
| Changes in fat free mass index (FFMI) | Measured in Kg/m2 | From baseline to 6 months |
| Changes in fat mass (FM) | Measured in Kilograms | From baseline to 6 months |
| Changes in fat mass index (FMI) | Measured in Kg/m2 | From baseline to 6 months |
| Changes in body cell mass (BCM) | Measured in kilograms | From baseline to 6 months |
| Changes in body cell mass index (BCMI) | Measured in Kg/m2 | From baseline to 6 months |
| Changes in appendicular skeletal muscle mass (ASMM) | Measured in kilograms | From baseline to 6 months |
| 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. | From baseline to 6 months |
| Changes in inflammatory biomarkers (assess kidney failure) | Measured as Fetuin A, FGF-21 and TGF-β1 by ELISA (ng/ml) | From baseline to 6 months |
| Changes in tubular and podocyte damage markers (assess kidney failure) | Measured as KIM-1 y NGAL by ELISA (ng/ml) | From baseline to 6 months |
| Changes in adipokines | Measured as leptin, adiponectin and resistin by ELISA (ng/ml) | From baseline to 6 months |
| 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 | From baseline to 6 months |
| 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 | From baseline to 6 months |
| 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 | From baseline to 6 months |
| Modifications in shear-wave renal elastography | Changes in kilopascals (kPA) in renal sinus | From baseline to 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D001836 | Body Weight Changes |