NCT05294770 (ORG-VLCD-2022) is a NA clinical trial of Optisource® Plus: Very Low Calorie Diet treatment in Obesity, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.

What condition does NCT05294770 study?

NCT05294770 studies Obesity, Glomerulopathy.

Is NCT05294770 still recruiting?

NCT05294770 is currently status unknown. Last updated 25 July 2022.

Last reviewed 2022-07-25 · How we verify

NCT05294770: ORG-VLCD-2022

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dietary Intervention in Obesity-related Glomerulopathy

Status unknown NA Last updated 25 July 2022

What this trial tests

NA trial testing Optisource® Plus: Very Low Calorie Diet treatment in Obesity in 60 participants. Status unknown.

Timeline

18 July 2022

Primary endpoint
1 September 2023

1 September 2024

Quick facts

Lead sponsor	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	18 July 2022
Primary completion	1 September 2023
Estimated completion	1 September 2024
Sites	1 location across Spain

Drugs / interventions tested

Optisource® Plus: Very Low Calorie Diet treatment
Hypocaloric Mediterranean Diet

Conditions studied

Obesity — all drugs for Obesity →
Glomerulopathy — all drugs for Glomerulopathy →

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →

Who can join

Adults 18 to 70, any sex, with Obesity or Glomerulopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05294770 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Last refreshed: 25 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05294770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing