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

Changes in the Hypothalamic-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)

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Overweight and Obesity
• Intervention / Treatment: Procedure: Bariatric surgery; Behavioral: Diet and lifestyle changes

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

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Andrea M Isidori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese patients come to our attention for weight loss interventions

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Obese patients with indication to bariatric surgery	Procedure: Bariatric surgery; Other Names: sleeve gastrectomy; gastric bypass; bilio-intestinal bypass
Group 2; Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes	Behavioral: Diet and lifestyle changes; Other Names: hypocaloric diet; physical exercise
Group 3; Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes	Behavioral: Diet and lifestyle changes; Other Names: hypocaloric diet; physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pituitary volume	Change in pituitary volume (mm3) from baseline to 3 years	0, +3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pituitary mean and standard deviation intensity	Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years	0, +3 years
Correlation of magnetic resonance parameters with anthropometric measurements	Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements	0, +3 years
Correlation of magnetic resonance parameters with pituitary axis function	Correlation analysis of pituitary mean and standard deviation intensity with pituitary axis function	0, +3 years
Correlation of magnetic resonance parameters with glyco-metabolic status	Correlation analysis of pituitary mean and standard deviation intensity with glyco-metabolic status	0, +3 years

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Andrea M Isidori, MD, PhD, Sapienza University of Rome

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Obesity; Metabolic syndrome; Overweight; Pituitary
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Disease; Overnutrition; Nutrition Disorders; Body Weight; Hypothalamic Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Pituitary Diseases; Metabolic Syndrome; Overweight
• Other Study ID Numbers: 4249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No