DyslipidemiaIDOMNCT07919158
Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
An observational study of Dyslipidemia and Obesity & Overweight, run by Rovere Querini Patrizia at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Obesity & Overweight
- How many people
- 900 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients evaluated at the Center of Excellence for Metabolic Health of IRCCS Ospedale San Raffaele between October 2024 and June 2026
Who may be able to join
- Age ≥ 18 years; overweight/obesity.
- BMI ≥ 25 kg/m2
- Availability of complete baseline Iipid profile (TC, LDL.-C, TG, HDL-C)
Who cannot join
- None. Given the retrospective observational nature of the study and its alignment with routine clinical practice, no exclusion criteria are applied. All patients meeting the predefined inclusion criteria are eligible for inclusion, with no additional selection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): An Observational, Retrospective Cohort Study at the San Raffaele Hospital Center for Metabolic Health
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.
Read the detailed description
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.
- Conditions
- Dyslipidemia, Obesity & Overweight
- Keywords
- OBESITY, DYSLIPIDEMIA, METABOLIC HEALTH
- Medical subject headings
- Dyslipidemias, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH OVERWEIGHT OR OBESITY | * Age ≥ 18 years; overweight/obesity. * BMI ≥ 25 kg/m2 * Availability of complete baseline Iipid profile (TC, LDL.-C, TG, HDL-C) No additional intrventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (3)
1. To estimate 10-year CV risk and characterize lipid, glycemic and inflammatory profiles across CV risk categories
- 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.
Measured: 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
- 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.
Measured: 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
Measured: baseline, 3 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Oct 2024
- Primary completion30 Jul 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rovere Querini Patrizia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rovere Querini Patrizia, IRCCS San Raffaele
- Investigators
- Patrizia Rovere Querini, MD, PhD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919158
- Sponsor's protocol ID
- IDOM
- Acronym
- IDOM
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): An Observational, Retrospective Cohort Study at the San Raffaele Hospital Center for Metabolic Health
- ClinicalTrials.gov ID
- NCT07919158
- Acronym / sponsor ID
- IDOM / IDOM
- Conditions
- Dyslipidemia, Obesity & Overweight
- Keywords
- OBESITY, DYSLIPIDEMIA, METABOLIC HEALTH
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Rovere Querini PatriziaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH OVERWEIGHT OR OBESITY | – | –* Age ≥ 18 years; overweight/obesity. * BMI ≥ 25 kg/m2 * Availability of complete baseline Iipid profile (TC, LDL.-C, TG, HDL-C) No additional intrventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients evaluated at the Center of Excellence for Metabolic Health of IRCCS Ospedale San Raffaele between October 2024 and June 2026
Key inclusion criteria (3 listed)
- Age ≥ 18 years; overweight/obesity.
- BMI ≥ 25 kg/m2
- Availability of complete baseline Iipid profile (TC, LDL.-C, TG, HDL-C)
Key exclusion criteria (1 listed)
- None. Given the retrospective observational nature of the study and its alignment with routine clinical practice, no exclusion criteria are applied. All patients meeting the predefined inclusion criteria are eligible for inclusion, with no additional selection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the prevalence of dyslipidemia and assess its association with metabolic health in adults with overweight or obesity.
Time frame: baseline
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).
3 secondary outcomes
1. To estimate 10-year CV risk and characterize lipid, glycemic and inflammatory profiles across CV risk categories
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
Time frame: baseline, 3 months and 6 months
4. Within-patient change from baseline to 3 and 6 months in metabolic parameters
Time frame: baseline, 3 and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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
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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.
Patrizia Rovere Querini, MD, PhD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and Obesity & Overweight, run by Rovere Querini Patrizia at 1 site in Italy.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the prevalence of dyslipidemia and assess its association with metabolic health in adults with overweight or obesity. (time frame: baseline). 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 5 Nov 2026.