The nutrition, cardiovascular wellness and diabetes project

Not Applicable

Completed

Conditions: 1. Obesity2. Type 2 diabetes3. Atherosclerosis3. Hypertension4. Liver steatosis5. Thyroid diseases6. Tumors7. Cognitive impairment
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN15840340

Lead Sponsor: niversity of Palermo - Dipartimento Biomedico di medicina Interna e Specialistica (DIBIMIS)

Brief Summary: 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29027533/ (added 11/12/2020) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29027533/ (added 11/12/2020) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29577560/ follow up results (added 11/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33670170/ results on association between dairy food intake and LDL-cholesterol levels (added 08/03/2021) 2017 Results article in https://doi.org/10.1155/2017/9294038 (added 12/09/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38649714/ (added 24/04/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 890

Inclusion Criteria

1. Aged 18 years or over
2. Residents in Palermo area (Italy)
3. Having been part of the 2011 cohort or being a new participant introduced by a participant to the 2011 study (up to a maximum of 300 new participants)

Exclusion Criteria

N/A

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Insulin resistance measured using HOMA-Index [fasting blood concentrations of insulin (mU/L) x glycemia (mmol/L) / 22.5], at baseline and 4 years from the first observation<br>2. Carotid atherosclerosis measured using ecography to measure the carotid intima-media thickness. This is measured at baseline and 4 years from the first observation

Secondary Outcome Measures

Name	Time	Method
1. Changes to the number and size of thyroid nodules are measured using ecography at baseline and 4 years from the first observation<br>2. Liver stenosis is measured by determining liver stiffness and controlled attenuation parameter (CAP) using a fibroscan at baseline and 4 years from the first observation<br>3. The level of mild cognitive impairment will be determined using mini-Mental State Examination (MMSE) score and clock-test score at baseline and 4 years from the first observation