AzTrials
AzTrials

Hypovitaminosis DViDONCT06115356

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

An observational study of Hypovitaminosis D and Obesity, run by University of Trieste at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypovitaminosis D, Obesity
What is being tested?
Vitamin D Plasma Level, Bioelectrical Impedance Analysis (BIA) technique and Ferritin
How many people
208 participants
Where
1 siteItaly
Study dates
1 Jan 2018to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with obesity eligible for bariatric surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Silvia Palmisano

    Trieste, 34100

Other trials in Italy

About this study

Official title: Hypovitaminosis D and "Metabolic" Inflammatory Status in Patients With Obesity: a Retrospective Cohort Study

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.

Read the detailed description

Introduction Obesity is a major health problem related to a cluster of chronic metabolic disorders and is associated with increased overall morbidity and mortality. Several studies proved that obesity is linked to a low grade of systemic chronic inflammatory status, considering the adipose tissue the largest metabolically active organ with endocrine, inflammatory, and immunological functions.

The "metabolic" inflammatory process leads to the release of inflammatory cytokines with subsequent systemic effects on insulin-sensitive organs, such as the liver which markedly suffers from the systemic proinflammatory environment. Vitamin D (25(OH)D) plays a key role in the regulation of mineral homeostasis by binding the vitamin D receptors, leading to an adequate calcium level to promote skeletal health. Furthermore, vitamin D has anti-inflammatory and immunoregulatory functions. It is an indispensable nutritive component that regulates the inflammatory microenvironment through several mechanisms such as the up-regulation of Mitogen-activated protein kinases (MAPKs) and inhibition of Nuclear Factor-Kappa B (NF-Kb) signaling pathways.

A low level of vitamin D in the visceral adipose tissue (VAT) induces more lipogenesis and less lipolysis promoting fat storage and obesity. The prevalence of vitamin D deficiency is 24% and 35% higher in overweight and obese people, respectively, compared to the general population. Many hypotheses have been proposed to explain the inverse correlation between Vitamin D and obesity:1) the storage of this fatsoluble nutrient in the exceeded VAT; 2) the higher plasma dilution of the Vitamin D in the obese patient compared to the normal-weight population; 3) the reduced sun exposure due to the stigma of obesity; 4) the presence of metabolic syndrome or type 2 diabetes that often co-exist with obesity; 5) molecular interactions between Vitamin D and pro-inflammatory cytokines.

Thus, hypovitaminosis D, inflammation, and obesity are three pathological conditions closely linked. In the literature, data explaining this relationship are still inconsistent, but crosstalk based on molecular signals exists.

On this basis, patients with obesity could be a high-achieving biological model helping to clarify the noncalcemic effects of vitamin D in regulating inflammation.

The first aim of the study is to assess the incidence of hypovitaminosis D in a cohort of obese patients; secondly, our purpose is to evaluate the correlation between hypovitaminosis D and inflammation's indices: inflammation-based prognostic scores, ferritin, C-reactive protein (CRP), inflammation grade on liver biopsy, and bioimpedance measures.

Materials and Methods This monocentric retrospective cohort study is based on a prospective database of consecutive obese patients referred to the General Surgery Department at Cattinara University Hospital in Trieste, Italy, between January 2018 and June 2021.

Patients were divided into three groups according to 25(OH) D levels: deficiency was defined as 25(OH) D levels ≤ 20 ng/mL, insufficiency between 21 and 29 ng/mL, and normal ≥ 30 ng/mL. The cohort was divided into three classes of obesity, according to BMI: grade I obesity 30.0-34.9 kg/m2; grade II obesity, 35.0-39.9 kg/m2; grade III obesity ≥40.0 kg/m2.

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. The PhA cutoff was not clearly defined in the literature, a value between 7.0 and 6.0 are found to be optimal in adulthood. Before surgery, the systemic inflammatory indices recorded were ferritin plasma level, CRP, and the following inflammation-based prognostic scores were considered for analysis: 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). CRP values≥ 5 mg/dL were considered pathological.

During the bariatric surgery, a liver biopsy was performed and analyzed by a single experienced pathologist blinded to all clinical and laboratory parameters. Patients with other forms of chronic liver disease, including suspected/confirmed hepatocellular carcinoma, alcoholic liver disease (>25 g/day alcohol consumption), or known hepatitis B virus, hepatitis C virus, and human immunodeficiency virus positivity were excluded. The histological diagnosis of nonalcoholic steatohepatitis (NASH) and fibrosis according to Kleiner-Brunt classification was detected. NASH was defined as a total no alcoholic fatty liver disease (NAFLD) activity score ≥ 5.

The study was conducted according to the STROBE Guidelines.

Statistical Analysis Continuous normal variables were expressed as mean ± standard deviation (SD); continuous non-normal variables as median and range (25 percentile-75 percentile). The Shapiro-Wilk test was performed to assess normality. Kruskal-Wallis non-parametric test was performed to identify differences in continuous variables of interest among the three groups. Post-hoc tests, and pair-wise comparisons using Mann-Whitney test, were conducted and corrected using the Holm method Categorical variables were expressed as absolute frequency and percentages and compared with Chi-Squared or Fisher-Exact Test when appropriate. The linear relationship between 25(OH) D levels and study continuous variables was assessed through the Spearman correlation coefficient. The most significant individual variables have been incorporated into a stepwise multiple linear regression (stepwise selection based on Akaike information criterion) to determine significant predictors of 25(OH) D levels. Two multiple linear regression analysis models were performed: 1) to estimate the predictive values of the bioelectrical impedance analysis and 2) to estimate the predictive values of inflammatory parameters. Beta and the standard error of Beta were reported as linear model results. P-Values ≤ 0.05 were considered statistically significant.

Data were analyzed using the R Statistical Software.

Being tested
Vitamin D Plasma Level, Bioelectrical Impedance Analysis (BIA) technique, Ferritin, C reactive protein (CRP), Inflammation-based prognostic scores
Keywords
Hypovitaminosis D, Obesity, Bariatric surgery, Inflammation
Medical subject headings
Vitamin D Deficiency, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D Plasma LevelDiagnostic test

    Blood test measured in ng/ml

  • Bioelectrical Impedance Analysis (BIA) techniqueDiagnostic 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.

  • FerritinDiagnostic 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 scoresDiagnostic 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 biopsyOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitamine D plasma level in patients with obesity

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

    Measured: enrollment time

Secondary outcomes (3)
  1. Vitamin D plasma level and systemic inflammation

    Correlation between inflammation-based prognostic scores, ferritin, C-reactive protein (CRP) and vitamine D levels

    Measured: enrollment time

  2. Vitamin D plasma level and liver fibrosis/inflammation

    Correlation between Vitamin D plasma level and liver fibrosis/inflammation

    Measured: enrollment time

  3. Vitamine D plasma level and bioimpedance parameters

    Correlation between Vitamine D level and bioimpedance parameters (BMI, phase angle (PhA), total body water (TBW), extracellular (ECW) and intracellular water (ICW), body fat index, and fat and muscular mass)

    Measured: enrollment time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start1 Jan 2018
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115356
Sponsor's protocol ID
Vit D Obesity
Acronym
ViDO
Status last verified
Nov 2023
First submitted
29 Oct 2023
Last updated
7 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypovitaminosis D and Obesity, run by University of Trieste at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitamine D plasma level in patients with obesity (time frame: enrollment time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in