An observational study in Dyslipidemia and Obesity & Overweight, sponsored by Rovere Querini Patrizia. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Rovere Querini Patrizia · Observational
A single-center, retrospective, observational study without experimental intervention, conducted at the Center of Excellence for Metabolic Health at IRCCS San Raffaele Hospital.
The primary objective of the study is to estimate the prevalence of dyslipidemia and evaluate its association with metabolic health status in overweight or obese subjects. Secondary objectives include characterizing cardiovascular risk; evaluating lipid, glycemic, and inflammatory profiles; analyzing longitudinal changes in these parameters during follow-up (where available); assessing the achievement of therapeutic targets recommended by ESC/EAS guidelines; and identifying predictors of metabolic response.
Approximately 900 patients are expected to be included, all enrolled at the Center of Excellence for Metabolic Health at IRCCS San Raffaele Hospital. Therefore, the total number of patients corresponds to that of the participating center.
A single-center, retrospective, observational study without experimental intervention, conducted at the Center of Excellence for Metabolic Health at IRCCS San Raffaele Hospital.
The study involves the analysis of clinical data collected during routine clinical practice from adult patients (≥18 years of age) who are overweight or obese (BMI ≥25 kg/m²) and were evaluated at the Center between October 2024 and June 2026. Only subjects with a complete baseline lipid profile (total cholesterol, LDL-C, HDL-C, and triglycerides) available at the initial visit will be included.
During the outpatient visit, patients undergo a multidisciplinary assessment comprising medical history, physical examination, anthropometric and body composition measurements, and metabolic screening via capillary sampling with real-time determination of total cholesterol, LDL-C, HDL-C, triglycerides, blood glucose, glycated hemoglobin (HbA1c), and C-reactive protein (CRP). This procedure is part of the Center's standard clinical practice and is not performed for research purposes. The primary objective of the study is to estimate the prevalence of dyslipidemia and evaluate its association with metabolic health status in overweight or obese subjects. Secondary objectives include characterizing cardiovascular risk; evaluating lipid, glycemic, and inflammatory profiles; analyzing longitudinal changes in these parameters during follow-up (where available); assessing the achievement of therapeutic targets recommended by ESC/EAS guidelines; and identifying predictors of metabolic response.
Approximately 900 patients are expected to be included, all enrolled at the Center of Excellence for Metabolic Health at IRCCS San Raffaele Hospital. Therefore, the total number of patients corresponds to that of the participating center.
The study entails no additional procedures, changes to the care pathway, or risks beyond those associated with standard clinical practice, as it is a retrospective analysis of existing data. Risks are limited to those concerning personal data confidentiality and will be minimized through data pseudonymization and processing in compliance with Regulation (EU) 2016/679 (GDPR) and applicable regulations.
There are no direct benefits for participants. The expected benefits are scientific and organizational in nature, consisting of a better understanding of the prevalence of dyslipidemia in overweight and obese patients, an assessment of the utility of lipid screening in an outpatient setting, and the identification of strategies to improve early diagnosis and cardiovascular risk management in this population.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's planned enrollment of 900 is above the median of 648 across 229 observational studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Rovere Querini Patrizia is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
all consecutive patients evaluated at the Center of Excellence for Metabolic Health of IRCCS Ospedale San Raffaele between October 2024 and June 2026
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Age ≥ 18 years; overweight/obesity. * BMI ≥ 25 kg/m2 * Availability of complete baseline Iipid profile (TC, LDL.-C, TG, HDL-C) No additional intrventions.
To estimate the prevalence of dyslipidemia and assess its association with metabolic health in adults with overweight or obesity.
1a. Prevalence of dyslipidemia (≥1 lipid criterion met): TC ≥200 mg/dL; fasting TG ≥150 mg/dL; HDL \<40 mg/dL (men) or \<50 mg/dL (women); LDL exceeding risk-category-specific threshold (\>116 / \>100 / \>70 / \>55 mg/dL for low / moderate / high / very high CV risk). 1b. Odds ratio (OR) for dyslipidemia across metabolic categories (intermediate vs. healthy; unhealthy vs. healthy). Metabolic health score (0-5): 1 point each for: (1) fasting glucose ≥100 mg/dL or HbA1c ≥5.7% or antidiabetic therapy; (2) SBP ≥130 or DBP ≥85 mmHg or antihypertensive therapy; (3) waist circumference ≥94 cm (men) / ≥80 cm (women); (4) hs-CRP \>0.3 mg/dL, (5) history of liver steatosis. Lipid parameters excluded to avoid circularity. Categories: healthy (0), intermediate (1-2), unhealthy (≥3).
Time frame: baseline
1. To estimate 10-year CV risk and characterize lipid, glycemic and inflammatory profiles across CV risk categories
1\. Proportion (n, %) of patients across CV risk categories (low, median, high, very high) according to SCORE2 and SCORE2-OP algorithms or other validated scores Lipid, glycemic and inflammatory profiles: mean values at baseline and absolute, mean and percentage changes in TC (mg/dl), LDL(mg/dl), HDL(mg/dl), TG(mg/dl), glucose(mg/dl), non-HDL (mg/dl), HbA1c (mmol/mol), CRP (mg/dl) from baseline to 3 and 6 months.
Time frame: baseline, 3 months and 6 months
2. To describe the distribution of Lp(a) values and assess its association with lipid, glycemic, inflammatory, and anthropometric paramet
2\. Distribution of Lp(a) values across clinical categories (\<75 nmol/L \[\<30 mg/dL\], 75-125 nmol/L \[30-50 mg/dL\], \>125 nmol/L \[\>50 mg/dL\]) and differences in TC, LDL-C, non-HDL-C, HDL-C, TG, hs-CRP, BMI, waist circumference, and metabolic burden score between patients with elevated (≥75 nmol/L \[≥30 mg/dL\]) versus normal (\<75 nmol/L \[\<30 mg/dL\]) Lp(a), in the subset with available measurement.
Time frame: baseline, 3 months and 6 months
4. Within-patient change from baseline to 3 and 6 months in metabolic parameters
TC, LDL-C, HDL-C, TG, non-HDL-C (mg/dL); HbA1c (mmol/mol); hs-CRP (mg/dL); BMI (kg/m²); fat mass and lean mass (kg); waist
Time frame: baseline, 3 and 6 month
Plan to share: Yes — The results of this study will be published in accordance with the principles of transparency, scientific integrity, and the institutional policies of IRCCS Ospedale San Raffaele. Authorship will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). Individuals who contribute substantially to the conception, design, analysis, or interpretation of the study will qualify for authorship, while other contributors will be appropriately acknowledged. Contributors who do not meet authorship criteria will be acknowledged appropriately. All manuscripts, abstracts, posters, and presentations arising from the study will be developed under the coordination and supervision of the Principal Investigator and will be subject to review by all co-authors prior to submission. Where applicable, review by the Sponsor may also be required in accordance with the terms of the study agreement; however, scientific interpretation and conclusions will remain under the respo
Supporting information: Study protocol
Time frame: START DATE SEPT 2026 UNTIL END OF STUDY
Access criteria: PI
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Jul 2026, 21 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Rovere Querini Patrizia