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
1 other identifier
observational
69
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedDecember 6, 2022
December 1, 2022
3.7 years
March 1, 2018
December 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pituitary volume
Change in pituitary volume (mm3) from baseline to 3 years
0, +3 years
Secondary Outcomes (4)
Evaluation of pituitary mean and standard deviation intensity
0, +3 years
Correlation of magnetic resonance parameters with anthropometric measurements
0, +3 years
Correlation of magnetic resonance parameters with pituitary axis function
0, +3 years
Correlation of magnetic resonance parameters with glyco-metabolic status
0, +3 years
Study Arms (3)
Group 1
Obese patients with indication to bariatric surgery
Group 2
Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes
Group 3
Overweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes
Interventions
Eligibility Criteria
Overweight and obese patients come to our attention for weight loss interventions
You may qualify if:
- BMI \> 25 Kg/m2
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea M Isidori
Rome, 00161, Italy
Related Publications (1)
Puliani G, Sbardella E, Cozzolino A, Sada V, Tozzi R, Andreoli C, Fiorelli M, Di Biasi C, Corallino D, Balla A, Paganini AM, Venneri MA, Lenzi A, Lubrano C, Isidori AM. Pituitary T1 signal intensity at magnetic resonance imaging is reduced in patients with obesity: results from the CHIASM study. Int J Obes (Lond). 2023 Oct;47(10):948-955. doi: 10.1038/s41366-023-01338-w. Epub 2023 Jul 21.
PMID: 37479795DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea M Isidori, MD, PhD
University of Roma La Sapienza
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 8, 2018
Study Start
November 1, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
December 6, 2022
Record last verified: 2022-12