Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
NCT07919158, Active not recruiting, Rovere Querini Patrizia
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health | ClinicalTrials.gov |
| NCT number | NCT07919158 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Enrollment | 900 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Rovere Querini Patrizia | ClinicalTrials.gov |
| Conditions | Dyslipidemia, Obesity & Overweight | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To estimate the prevalence of dyslipidemia and assess its association with metabolic health in adults with overweight or obesity. | 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). | ClinicalTrials.gov |
| Secondary | 1. To estimate 10-year CV risk and characterize lipid, glycemic and inflammatory profiles across CV risk categories | baseline, 3 months and 6 months | 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. | ClinicalTrials.gov |
| Secondary | 2. To describe the distribution of Lp(a) values and assess its association with lipid, glycemic, inflammatory, and anthropometric paramet | baseline, 3 months and 6 months | 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. | ClinicalTrials.gov |
| Secondary | 4. Within-patient change from baseline to 3 and 6 months in metabolic parameters | baseline, 3 and 6 month | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)