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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-30

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)

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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:

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

Conditions

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Overweight and Obesity Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Obese patients with indication to bariatric surgery

Bariatric surgery

Intervention Type PROCEDURE

Group 2

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

Diet and lifestyle changes

Intervention Type BEHAVIORAL

Group 3

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

Diet and lifestyle changes

Intervention Type BEHAVIORAL

Interventions

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Bariatric surgery

Intervention Type PROCEDURE

Diet and lifestyle changes

Intervention Type BEHAVIORAL

Other Intervention Names

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sleeve gastrectomy gastric bypass bilio-intestinal bypass hypocaloric diet physical exercise

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No