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NCT04233528
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
NA trial testing Evaluation of systemic skin microvascular endothelial function in Obesity in 112 participants. Completed in 30 December 2022.
10 December 2022
Quick facts
| Lead sponsor | National Institute of Cardiology, Laranjeiras, Brazil |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 112 |
| Start date | 1 June 2019 |
| Primary completion | 10 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Evaluation of systemic skin microvascular endothelial function
Conditions studied
- Obesity — all drugs for Obesity →
- Dyslipidemias — all drugs for Dyslipidemias →
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Who can join
Adults 18 to 55, any sex, with Obesity or Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer. However, recently a new classification has emerged about obesity, the metabolically healthy obesity (MHO). According to the definition of the term, MHO represents obesity that occurs segregated from the metabolic syndrome criteria defined by the International Diabetes Federation (IDF). However, as there is still disagreement about the definition of MHO, the cardiovascular risk of these individuals is also uncertain. This phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to MUO, represents a higher risk of developing CVDs. The hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of CVD. In the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04233528
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Evaluation of systemic skin microvascular endothelial function
Trials testing the same drug.
- NCT05464849 — Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension · completed
Other recruiting trials for Obesity
Currently open trials in the same condition.
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- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting
Other National Institute of Cardiology, Laranjeiras, Brazil trials
Trials by the same sponsor.
- NCT05728047 — Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery · completed
- NCT04946396 — Effects of Continuous Dexmedetomidine Infusion on Systemic Microvascular Function in Laparoscopic Cholecystecthomy · NA · completed
- NCT05464849 — Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension · completed
- NCT05864729 — The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes · NA · completed
- NCT04406545 — Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of COVID-19. · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04233528 (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 National Institute of Cardiology, Laranjeiras, Brazil
- Last refreshed: 18 January 2023
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/NCT04233528.
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