The synergetic effect of Bergamot and Cynara Cardunculus extract on blood vessels in patients with type 2 diabetes and non-alcoholic fatty liver disease

Not Applicable

Completed

• Conditions: AFLD and endothelial dysfunction oxidative stress in type 2 diabetes; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus with peripheral circulatory complications

• Registration Number: ISRCTN33165861
• Lead Sponsor: utramed Scarl

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32670822/ (added 01/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-04
• Study Completion: 2019-12-31
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Men or women = 18 years
2. Written informed consent
3. History of at least 12 months of type 2 diabetes mellitus
4. History of at least 12 months of NAFLD with no excessive alcohol consumption (less than 20 g/day for men and 10 g/day for women)
5. Fatty liver
6. Hepato-renal index between 2.5 and 3.5

Exclusion Criteria

1. Positive pregnancy test (ßHCG) performed at the selection visit or result not available, women who are pregnant, women who are breast-feeding, women of childbearing potential not using estro-progestative or progestative or intrauterine contraception, or women using estro-progestative or progestative or inteauterine contraception, but who consider stopping it during the planned duration of the study
2. History of alcoholism or drug abuse
3. Patients with viral or autoimmune liver disease
4. Patients unlikely to co-operate in the study or to comply well with the treatment or with the study visits
5. History of severe mental or psychiatric disorder, severe depression or history of severe depression, e.g. requiring an hospitalization or at high risk of suicide attempt
6. Participation in another study at the same time or within the preceding 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> At 16-weeks:<br> Epato-renal index, transaminases, gamma glutamyl transferase, measured by blood sample.<br>

Secondary Outcome Measures

Name	Time	Method
<br> At 16-weeks:<br> EndoPat measures of Reactive vasodilatation, malondialdehyde levels, inflammation markers, measured by blood sample.<br>