NAFLD and endothelial dysfunction oxidative stress in type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus with peripheral circulatory complications
Conditions
Interventions
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
n?=?20) or placebo (300 mg of maltodextrin
n?=?20). Each participant will be required to maintain their habitual diet, physical activity during the study. The number of supplements not consumed and log reviews will be used to assess complianc
Mod. Aplio, Toshiba, Japan) equipped with a convex-array probe. All subjects will be evaluated in the left lateral recumbent position of 15° - 20° to see the liver parenchyma and the right kidney co
Sponsors
Nutramed Scarl
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 16-weeks: Epato-renal index, transaminases, gamma glutamyl transferase, measured by blood sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| At 16-weeks: EndoPat measures of Reactive vasodilatation, malondialdehyde levels, inflammation markers, measured by blood sample. | — |
Countries
Italy
Contacts
Public Contactvincenzo mollace
Outcome results
None listed