Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity

Metabolic Syndrome Clinical Trial

— CHIASM  

Official title:

Changes in the Hypothalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458533
• Other study ID #: 4249
• Status: Completed
• Start date: November 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to identify new morphological and quantitative magnetic imaging parameters of pituitary gland and sellar region in overweight and obese patient at baseline and after 3 years, dividing patients in 3 groups (weight loss through diet and lifestyle changes, weight loss through bariatric surgery, no weight loss)

Description:

This longitudinal prospective study in overweight and obese patients aims to identify and characterize new morphological and quantitative MRI parameters of pituitary gland and sellar region assessed by texture analysis with a specific software (ImageJ©). These parameters will be correlated them to hypothalamic-pituitary-peripheral axis function, metabolism and body composition.

Data will be detected at baseline and at 3 years follow-up to quantitatively identify the different pituitary MRI patterns in 3 groups:

1. patients without weight modifies

2. patients with weight loss obtain through diet and lifestyle changes

3. patients with weight loss obtained through bariatric surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI > 25 Kg/m2

Exclusion Criteria:

• Malignant neoplasia;

• Current use of psychotropic drugs;

• Chronic renal failure;

• Pituitary macroadenomas and craniopharyngiomas;

• Contraindications to MRI execution (p. e. pace-maker, metal foreign bodies like slivers, non MRI compatible vascular clips or prosthesis)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Overweight
• Overweight and Obesity
• Pituitary Diseases
• Syndrome

Intervention

Procedure:
• Bariatric surgery

Behavioral:
• Diet and lifestyle changes

Locations

Country	Name	City	State
Italy	Andrea M Isidori	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pituitary volume	Change in pituitary volume (mm3) from baseline to 3 years	0, +3 years
Secondary	Evaluation of pituitary mean and standard deviation intensity	Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years	0, +3 years
Secondary	Correlation of magnetic resonance parameters with anthropometric measurements	Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements	0, +3 years
Secondary	Correlation of magnetic resonance parameters with pituitary axis function	Correlation analysis of pituitary mean and standard deviation intensity with pituitary axis function	0, +3 years
Secondary	Correlation of magnetic resonance parameters with glyco-metabolic status	Correlation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status	0, +3 years