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NCT04314167
Effect of Serum LDL Cholesterol Concentration on Pancreatic Insulin Secretion
NA trial testing Lowering cholesterol concentrations by PCSK-9 inhibitor in Hypercholesterolemia in 9 participants. Terminated before completion.
1 March 2024
Quick facts
| Lead sponsor | University Hospital Tuebingen |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 9 |
| Start date | 28 July 2020 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Lowering cholesterol concentrations by PCSK-9 inhibitor — full drug profile →
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
- Insulin Resistance — all drugs for Insulin Resistance →
- Insulin Secretion — all drugs for Insulin Secretion →
Sponsor
University Hospital Tuebingen
Who can join
Adults 18 to 75, any sex, with Hypercholesterolemia or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Dyslipidemia is characterized by low levels of HDLs, hypertriglyceridemia as well as an increases proportion of small dense LDLs. Changes in lipoprotein particles and its concentrations, especially increased levels of pro-atherogenic LDL particles play an important role in the development of cardiovascular diseases. It is well established that statin/PCSK9-inhibitor treatment is very effective in lowering LDL cholesterol levels and therefore in preventing cardiovascular events. Besides the beneficial effects on cardiovascular system, these therapies are unfortunately linked to increased risk for type 2 diabetes. However underlying mechanisms for the association between LDL cholesterol levels and the risk for type 2 diabetes remains largely unknown.Type 2 diabetes is especially characterized by insulin resistance and impaired insulin secretion from pancreatic beta-cells. Insulin resistance alone is insufficient to cause type 2 diabetes, as long as the ß-cell is able to compensate for the increased demand for insulin. Once this compensatory mechanism reaches its physiological limits, individuals progress to type 2 diabetes. Accordingly we aimed to investigate the associations between LDL cholesterol concentrations and the key issue in the pathogenesis of type 2 diabetes, insulin secretion before and after lowering cholesterol concentration by treatment with Evolocumab for 12 weeks in patients with medical indication for a treatment with a PCSK9-inhibitor. Therefore, patients will either undergo a hyperglycemic clamp or a oral glucose tolerance test in randomized manner.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04314167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other University Hospital Tuebingen trials
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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 NCT04314167 (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 University Hospital Tuebingen
- Last refreshed: 16 May 2024
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/NCT04314167.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing