Changes in the Hypothalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Pituitary volume
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Andrea M. Isidori
MD, PhD
University of Roma La Sapienza
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Pituitary volume
Time Frame: 0, +3 years
Change in pituitary volume (mm3) from baseline to 3 years
Secondary Outcomes
- Evaluation of pituitary mean and standard deviation intensity(0, +3 years)
- Correlation of magnetic resonance parameters with anthropometric measurements(0, +3 years)
- Correlation of magnetic resonance parameters with pituitary axis function(0, +3 years)
- Correlation of magnetic resonance parameters with glyco-metabolic status(0, +3 years)