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The nutrition, cardiovascular wellness and diabetes project

Influence of nutritional factors on cardiovascular and metabolic risk

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15840340
Enrollment
1000
Registered
2015-08-25
Start date
2015-03-21
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Obesity 2. Type 2 diabetes 3. Atherosclerosis 3. Hypertension 4. Liver steatosis 5. Thyroid diseases 6. Tumors 7. Cognitive impairment Nutritional, Metabolic, Endocrine 1. Obesity 2. Type 2 diabetes 3. Atherosclerosis 3. Hypertension 4. Liver steatosis 5. Thyroid diseases 6. Tumors 7. Cognitive impairment

Interventions

The 2011 study was an observational, cross-sectional study carried out in Palermo, the largest city in Sicily, Italy. From March 28th to April 10th 2011, groups composed of physicians (n= 5) and dieti

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
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 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

MeasureTime frame
1. Changes to the number and size of thyroid nodules are measured using ecography at baseline and 4 years from the first observation 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 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

Countries

Italy

Contacts

Public ContactSilvio Buscemi
silvio.buscemi@unipa.it+3 991 655 4580

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026