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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03458533
Acronym
CHIASM
Enrollment
69
Registered
2018-03-08
Start date
2016-11-30
Completion date
2020-06-30
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Overweight and Obesity

Keywords

Pituitary, Obesity, Overweight, Metabolic syndrome, MRI

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

Interventions

PROCEDUREBariatric surgery
BEHAVIORALDiet and lifestyle changes

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pituitary volume0, +3 yearsChange in pituitary volume (mm3) from baseline to 3 years

Secondary

MeasureTime frameDescription
Evaluation of pituitary mean and standard deviation intensity0, +3 yearsChanges in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years
Correlation of magnetic resonance parameters with anthropometric measurements0, +3 yearsCorrelation analysis of pituitary mean and standard deviation intensity with anthropometric measurements
Correlation of magnetic resonance parameters with pituitary axis function0, +3 yearsCorrelation analysis of pituitary mean and standard deviation intensity with pituitary axis function
Correlation of magnetic resonance parameters with glyco-metabolic status0, +3 yearsCorrelation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026