Hypovitaminosis D and "Metabolic" Inflammatory Status in Patients With Obesity

NCT06115356 | Completed

• 1 other identifier: Vit D Obesity
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Since obesity is related to systemic chronic inflammatory status and hypovitaminosis D, the study aimed to assess the incidence of hypovitaminosis D in obese patients and the correlations between vitamin D levels, inflammation indices, and bioimpedance measures. A retrospective study was conducted on a cohort of obese patients. The inflammation-based prognostic scores, diagnosis of liver fibrosis, systemic inflammatory indices, and bioimpedance measures were analyzed. The linear relationship between vitamin D levels and continuous variables was assessed through the Spearman correlation coefficient, and to determine significant predictors of vitamin D levels a stepwise multiple linear regression was used.

Conditions

Hypovitaminosis D; Obesity

Keywords

Hypovitaminosis D; Obesity; Bariatric surgery; Inflammation

Outcome Measures

Primary Outcomes (1)

• Vitamine D plasma level in patients with obesity

  To assess the incidence of hypovitaminosis D in a cohort of patients with obesity

  enrollment time

Secondary Outcomes (3)

• Vitamin D plasma level and systemic inflammation

  enrollment time

• Vitamin D plasma level and liver fibrosis/inflammation

  enrollment time

• Vitamine D plasma level and bioimpedance parameters

  enrollment time

Interventions

Vitamin D Plasma Level DIAGNOSTIC_TEST

Blood test measured in ng/ml

Bioelectrical Impedance Analysis (BIA) technique DIAGNOSTIC_TEST

Measurements of body composition were conducted with Bioelectrical Impedance Analysis (BIA) technique, asking the participants to stand on the device barefoot to complete the analysis. Among all parameters, BMI, phase angle (PhA), total body water (TBW), extracellular (ECW) and intracellular water (ICW), body fat index, and fat and muscular mass were recorded.

Ferritin DIAGNOSTIC_TEST

Ferritin plasma levels were measured in μg/L

C reactive protein (CRP) DIAGNOSTIC_TEST

CRP plasma levels were measured in mg/L

Inflammation-based prognostic scores DIAGNOSTIC_TEST

Glasgow Prognostic Score/modified Glasgow Prognostic Score (GPS/mGPS), Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte ratio (PLR), Lymphocyte-to-monocyte ratio (LMR), Systemic immune-inflammation index (SII) were calculated using blood test results

Liver biopsy OTHER

A liver biopsy was used to study nonalcoholic steatohepatitis (NASH) and fibrosis according to the Kleiner-Brunt classification

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity eligible for bariatric surgery

You may qualify if:

• BMI\> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines)

You may not qualify if:

• Patients affected by active liver viral infection
• Patient alcohol or drug addicted
• Incompetent patients

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Silvia Palmisano

Trieste, 34100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsies were studied to analyze fibrosis and inflammation grade

MeSH Terms

Conditions

Vitamin D Deficiency; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Silvia Palmisano, MD

  University of Trieste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

IT (1)