ObesityORG-VLCD-2022NCT05294770
Dietary Intervention in Obesity-related Glomerulopathy
A study testing Optisource® Plus: Very Low Calorie Diet treatment and Hypocaloric Mediterranean Diet in people with Obesity and Glomerulopathy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Glomerulopathy
- What is being tested?
- Optisource® Plus: Very Low Calorie Diet treatment and Hypocaloric Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga.
Málaga, 29009
José Carlos Fernández García, MD, PhD, +34 951034016
About this study
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
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.
Read the 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.
- Conditions
- Obesity, Glomerulopathy
- Being tested
- Optisource® Plus: Very Low Calorie Diet treatment, Hypocaloric Mediterranean Diet
- Keywords
- Albuminuria, Obesity, kidney function, diet, elastography, weight loss
- Medical subject headings
- Obesity, Albuminuria, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optisource® Plus: Very Low Calorie Diet treatmentOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Hypocaloric Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in albuminuria
Albuminuria in mg/g
Measured: From baseline to 6 months
Secondary outcomes (21)
Changes in glomerular filtration (kidney function)
Calculated with the formula CKD-EPI and measured in ml/min/1,73 m2
Measured: From baseline to 6 months
Cystatin C levels (kidney function)
Cystatin C in ng/ml
Measured: From baseline to 6 months
BMI (body mass index)
kg/m2
Measured: From baseline to 6 months
Changes in total body water (TBW)
Measured in liters
Measured: From baseline to 6 months
Changes in extracellular water (ECW)
Measured in liters
Measured: From baseline to 6 months
Changes in intracellular water (ICW)
Measured in liters
Measured: From baseline to 6 months
Changes in fat free mass (FFM)
Measured in kilograms
Measured: From baseline to 6 months
Changes in fat free mass index (FFMI)
Measured in Kg/m2
Measured: From baseline to 6 months
Changes in fat mass (FM)
Measured in Kilograms
Measured: From baseline to 6 months
Changes in fat mass index (FMI)
Measured in Kg/m2
Measured: From baseline to 6 months
Changes in body cell mass (BCM)
Measured in kilograms
Measured: From baseline to 6 months
Changes in body cell mass index (BCMI)
Measured in Kg/m2
Measured: From baseline to 6 months
Changes in appendicular skeletal muscle mass (ASMM)
Measured in kilograms
Measured: 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.
Measured: 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)
Measured: 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)
Measured: From baseline to 6 months
Changes in adipokines
Measured as leptin, adiponectin and resistin by ELISA (ng/ml)
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to 6 months
Modifications in shear-wave renal elastography
Changes in kilopascals (kPA) in renal sinus
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start18 Jul 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Carlos Fernández García, MD, PhD., Principal investigator, Hospital Regional Universitario de Málaga - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294770
- Sponsor's protocol ID
- ORG-VLCD-2022
- Acronym
- ORG-VLCD-2022
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05294770
- Acronym / sponsor ID
- ORG-VLCD-2022 / ORG-VLCD-2022
- Conditions
- Obesity, Glomerulopathy
- Keywords
- Albuminuria, Obesity, kidney function, diet, elastography, weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very Low Calorie Diet (VLCD) | Experimental | Other: Optisource® Plus: Very Low Calorie Diet treatmentPatients 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 | Other: Hypocaloric Mediterranean DietRandomized 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optisource® Plus: Very Low Calorie Diet treatmentPatients 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 | Very Low Calorie Diet (VLCD) |
| Hypocaloric Mediterranean DietRandomized 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 |
Primary outcome
Changes in albuminuria
Time frame: From baseline to 6 months
Albuminuria in mg/g
21 secondary outcomes
Changes in glomerular filtration (kidney function)
Time frame: From baseline to 6 months
Cystatin C levels (kidney function)
Time frame: From baseline to 6 months
BMI (body mass index)
Time frame: From baseline to 6 months
Changes in total body water (TBW)
Time frame: From baseline to 6 months
Changes in extracellular water (ECW)
Time frame: From baseline to 6 months
Changes in intracellular water (ICW)
Time frame: From baseline to 6 months
Changes in fat free mass (FFM)
Time frame: From baseline to 6 months
Changes in fat free mass index (FFMI)
Time frame: From baseline to 6 months
Changes in fat mass (FM)
Time frame: From baseline to 6 months
Changes in fat mass index (FMI)
Time frame: From baseline to 6 months
Changes in body cell mass (BCM)
Time frame: From baseline to 6 months
Changes in body cell mass index (BCMI)
Time frame: From baseline to 6 months
Changes in appendicular skeletal muscle mass (ASMM)
Time frame: From baseline to 6 months
Changes in blood pressure
Time frame: From baseline to 6 months
Changes in inflammatory biomarkers (assess kidney failure)
Time frame: From baseline to 6 months
Changes in tubular and podocyte damage markers (assess kidney failure)
Time frame: From baseline to 6 months
Changes in adipokines
Time frame: From baseline to 6 months
Modifications in gut microbiota richness and diversity
Time frame: From baseline to 6 months
Modifications in gut microbiota abundance and composition
Time frame: From baseline to 6 months
Modifications in gut microbiota functionality
Time frame: From baseline to 6 months
Modifications in shear-wave renal elastography
Time frame: From baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Carlos Fernández García, MD, PhD. principal investigator
Hospital Regional Universitario de Málaga - FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optisource® Plus: Very Low Calorie Diet treatment and Hypocaloric Mediterranean Diet in people with Obesity and Glomerulopathy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Carlos Fernández García, MD, PhD. (+34 951034016, josecarlosfdezgarcia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in albuminuria (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.