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

Completed

• Conditions: Metabolic Syndrome; Overweight and Obesity
• Interventions: Behavioral: Diet and lifestyle changes; Procedure: Bariatric surgery

• Registration Number: NCT03458533
• Lead Sponsor: University of Roma La Sapienza

Brief 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)

Detailed 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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Diet and lifestyle changes	Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes
Group 1	Bariatric surgery	Obese patients with indication to bariatric surgery
Group 3	Diet and lifestyle changes	Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes

Primary Outcome Measures

Name	Time	Method
Pituitary volume	0, +3 years	Change in pituitary volume (mm3) from baseline to 3 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of pituitary mean and standard deviation intensity	0, +3 years	Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years
Correlation of magnetic resonance parameters with anthropometric measurements	0, +3 years	Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements
Correlation of magnetic resonance parameters with pituitary axis function	0, +3 years	Correlation analysis of pituitary mean and standard deviation intensity with pituitary axis function
Correlation of magnetic resonance parameters with glyco-metabolic status	0, +3 years	Correlation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status

Trial Locations

Locations (1)

Andrea M Isidori; 🇮🇹 Rome, Italy