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

Study Overview
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Brief Summary
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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
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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: patients without weight modifies patients with weight loss obtain through diet and lifestyle changes patients with weight loss obtained through bariatric surgery

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

Conditions
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Overweight and Obesity, Metabolic Syndrome

Intervention / Treatment
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* Procedure: Bariatric surgery
* Behavioral: Diet and lifestyle changes


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Obese patients with indication to bariatric surgery | Procedure: Bariatric surgery<br> <br> * Other names: bilio-intestinal bypass;|
| Group 2<br>Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes | Behavioral: Diet and lifestyle changes<br> <br> * Other names: physical exercise;|
| Group 3<br>Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes | Behavioral: Diet and lifestyle changes<br> <br> * Other names: physical exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pituitary volume | Change in pituitary volume (mm3) from baseline to 3 years | 0, +3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Correlation of magnetic resonance parameters with anthropometric measurements | Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements | 0, +3 years | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Pituitary, Obesity, Overweight, Metabolic syndrome