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Completed

NCT Number: NCT03458533

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

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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Key information

Conditions

Overweight and Obesity Body Weight Brain Diseases Central Nervous System Diseases Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypothalamic Diseases Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pituitary Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea M Isidori

Rome, 00161, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bariatric surgery

Procedure

Other names: sleeve gastrectomy, gastric bypass, bilio-intestinal bypass

Diet and lifestyle changes

Behavioral

Other names: hypocaloric diet, physical exercise

Primary outcomes

  1. Pituitary volume

    Time frame: 0, +3 years

    Change in pituitary volume (mm3) from baseline to 3 years

Secondary outcomes

  1. Evaluation of pituitary mean and standard deviation intensity

    Time frame: 0, +3 years

    Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years

  2. Correlation of magnetic resonance parameters with anthropometric measurements

    Time frame: 0, +3 years

    Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements

  3. Correlation of magnetic resonance parameters with pituitary axis function

    Time frame: 0, +3 years

    Correlation analysis of pituitary mean and standard deviation intensity with pituitary axis function

  4. Correlation of magnetic resonance parameters with glyco-metabolic status

    Time frame: 0, +3 years

    Correlation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: CHIASM

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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