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NCT00328536
Effects of Treatment With Omacor for 6 Weeks on Preprandial and Postprandial Endothelial Function Following a High Fat Meal in Patients With Type 2 Diabetes Mellitus
Phase 4 trial testing Omacor in Atherosclerosis in 34 participants. Completed in 1 November 2008.
1 November 2008
Quick facts
| Lead sponsor | Ruhr University of Bochum |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 1 April 2007 |
| Primary completion | 1 November 2008 |
| Estimated completion | 1 November 2008 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Omacor (OMEGA-3ACID ETHYL ESTERS) — full drug profile →
Conditions studied
- Atherosclerosis — all drugs for Atherosclerosis →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Ruhr University of Bochum
Who can join
Adults 35 to 70, any sex, with Atherosclerosis or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Postprandial (2, 4 and 6 hours) flow-mediated vasodilation after a 6-week treatment with Omacor
Sponsor's own description
The purpose of the study is to determine whether a 6-week treatment with 4 g Omacor/day improves the baseline and postprandial endothelial function (after a high-fat meal) in patients with type 2 diabetes mellitus.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of n-3 polyunsaturated fatty acids (PUFAs) on circulating adiponectin and leptin in subjects with type 2 diabetes mellitus.
Stirban A, Nandrean S, Götting C, Stratmann B, et al · · 2014 · cited 14× · PMID 24356795 · DOI 10.1055/s-0033-1363225
Verify or expand the search:
- PubMed search for NCT00328536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omacor
Trials testing the same drug.
- NCT03438955 — Phase I Drug-drug Interaction of Omega-3 and Atorvastatin · Phase 1 · unknown
- NCT03018041 — The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation · Phase 3 · completed
Other recruiting trials for Atherosclerosis
Currently open trials in the same condition.
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- NCT06676046 — Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions · recruiting
- NCT06694012 — Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2 · recruiting
Other Ruhr University of Bochum trials
Trials by the same sponsor.
- NCT07432945 — In Vivo Exposure vs. Videochat-Based Vicarious Exposure · NA · recruiting
- NCT06255821 — The Effect of Time on Generalization of Exposure-based Benefit · NA · completed
- NCT05824884 — Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights · NA · recruiting
- NCT05798078 — The Relationship Between Social Anxiety and Anxious Thinking Styles · NA · completed
- NCT05780203 — CBM in the Context of Exposure for Acrophobia · NA · 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 NCT00328536 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruhr University of Bochum
- Last refreshed: 7 May 2009
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/NCT00328536.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing