| Trial ID: | L0721 |
| Source ID: | ISRCTN33165861
|
| Associated Drug: |
Bergamot
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| Title: |
The synergetic effect of Bergamot and Cynara Cardunculus Extract on vascular inflammation and endothelial dysfunction in patients with Type 2 Diabetes and NAFLD: a double blind, randomized, placebo-controlled study.
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD and endothelial dysfunction oxidative stress in type 2 diabetes <br>Nutritional, Metabolic, Endocrine <br>Type 2 diabetes mellitus with peripheral circulatory complications
|
| Interventions: |
<br> Participants will be randomized using a random number generator in Excel software to receive oral administration of BPF (300 mg/daily; n=20), CyC (300 mg/daily; n=20) or a formulation of both extracts (Bergacyn; 150 mg + 150 mg/daily;
|
| Outcome Measures: |
<br> At 16-weeks:<br> Epato-renal index, transaminases, gamma glutamyl transferase, measured by blood sample.<br> <br> At 16-weeks:<br> EndoPat measures of Reactive vasodilatation, malondialdehyde levels, inflammation markers, measured by blood sample.<br>
|
| Sponsor/Collaborators: |
Nutramed Scarl
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
80
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized double-blind placebo-controlled study (Prevention)
|
| Start Date: |
04/11/2019
|
| Completion Date: |
31/12/2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
10 December 2019
|
| Locations: |
Italy
|
| URL: |
http://isrctn.com/ISRCTN33165861
|
