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

University of Roma La Sapienza

Status: Completed

Conditions: Overweight and Obesity; Metabolic Syndrome

Treatments: Procedure: Bariatric surgery; Behavioral: Diet and lifestyle changes

Study type: Observational

Funder types: Other

Identifiers

NCT03458533

4249

Details and patient eligibility

About

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)

Full 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

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

69 participants in 3 patient groups

Group 1

Description:

Obese patients with indication to bariatric surgery

Treatment:

Procedure: Bariatric surgery

Group 2

Description:

Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes

Treatment:

Behavioral: Diet and lifestyle changes

Group 3

Description:

Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes

Treatment:

Behavioral: Diet and lifestyle changes