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Trial record 68 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03458533
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea M. Isidori, University of Roma La Sapienza

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)

Condition or disease Intervention/treatment
Overweight and Obesity Metabolic Syndrome 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

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pituitary volume [ Time Frame: 0, +3 years ]
    Change in pituitary volume (mm3) from baseline to 3 years


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Overweight and obese patients come to our attention for weight loss interventions
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458533


Contacts
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Contact: Andrea M Isidori, MD, PhD 00390649970540 andrea.isidori@uniroma1.it

Locations
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Italy
Andrea M Isidori Recruiting
Rome, Italy, 00161
Contact: Andrea M Isidori, MD, PhD    00390649970540    andrea.isidori@uniroma1.it   
Principal Investigator: Andrea M Isidori, MD, PhD         
Sub-Investigator: Giulia Puliani, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Andrea M Isidori, MD, PhD Sapienza University of Rome

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Responsible Party: Andrea M. Isidori, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03458533     History of Changes
Other Study ID Numbers: 4249
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea M. Isidori, University of Roma La Sapienza:
Pituitary
Obesity
Overweight
Metabolic syndrome
MRI

Additional relevant MeSH terms:
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Metabolic Syndrome
Body Weight
Syndrome
Obesity
Overweight
Pituitary Diseases
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases