Overweight and ObesityCHIASMNCT03458533
Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
An observational study of Overweight and Obesity and Metabolic Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- Bariatric surgery and Diet and lifestyle changes
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2016to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Overweight and obese patients come to our attention for weight loss interventions
Who may be able to join
- BMI > 25 Kg/m2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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:
- patients without weight modifies
- patients with weight loss obtain through diet and lifestyle changes
- patients with weight loss obtained through bariatric surgery
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Being tested
- Bariatric surgery, Diet and lifestyle changes
- Keywords
- Pituitary, Obesity, Overweight, Metabolic syndrome, MRI
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called sleeve gastrectomy, gastric bypass, bilio-intestinal bypass
Diet and lifestyle changesBehavioural
Also called hypocaloric diet, physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Obese patients with indication to bariatric surgery Receives: Procedure: Bariatric surgery | |
| Group 2 | Overweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes Receives: Behavioral: 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 Receives: Behavioral: Diet and lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pituitary volume
Change in pituitary volume (mm3) from baseline to 3 years
Measured: 0, +3 years
Secondary outcomes (4)
Evaluation of pituitary mean and standard deviation intensity
Changes in new quantitative magnetic imaging parameters of pituitary gland from baseline to 3 years
Measured: 0, +3 years
Correlation of magnetic resonance parameters with anthropometric measurements
Correlation analysis of pituitary mean and standard deviation intensity with anthropometric measurements
Measured: 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
Measured: 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
Measured: 0, +3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study startNov 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Isidori, University of Roma La Sapienza
- Investigators
- Andrea M Isidori, MD, PhD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458533
- Sponsor's protocol ID
- 4249
- Acronym
- CHIASM
- Status last verified
- Dec 2022
- First submitted
- 1 Mar 2018
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37479795
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Hypothalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
- ClinicalTrials.gov ID
- NCT03458533
- Acronym / sponsor ID
- CHIASM / 4249
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Keywords
- Pituitary, Obesity, Overweight, Metabolic syndrome, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- patients without weight modifies
- patients with weight loss obtain through diet and lifestyle changes
- patients with weight loss obtained through bariatric surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Bariatric surgeryObese patients with indication to bariatric surgery |
| Group 2 | – | Behavioral: Diet and lifestyle changesOverweight or obese patients without indication to bariatric surgery, able to obtain weight loss trough diet and lifestyle changes |
| Group 3 | – | Behavioral: Diet and lifestyle changesOverweight or obese patients without indication to bariatric surgery, not able to obtain weight loss trough diet and lifestyle changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese patients come to our attention for weight loss interventions
Key inclusion criteria (1 listed)
- BMI > 25 Kg/m2
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryAlso: sleeve gastrectomy, gastric bypass, bilio-intestinal bypass | Procedure or surgery | Group 1 |
| Diet and lifestyle changesAlso: hypocaloric diet, physical exercise | Behavioural | Group 2, Group 3 |
Primary outcome
Pituitary volume
Time frame: 0, +3 years
Change in pituitary volume (mm3) from baseline to 3 years
4 secondary outcomes
Evaluation of pituitary mean and standard deviation intensity
Time frame: 0, +3 years
Correlation of magnetic resonance parameters with anthropometric measurements
Time frame: 0, +3 years
Correlation of magnetic resonance parameters with pituitary axis function
Time frame: 0, +3 years
Correlation of magnetic resonance parameters with glyco-metabolic status
Time frame: 0, +3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 37479795Puliani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea M Isidori, MD, PhD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Metabolic Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pituitary volume (time frame: 0, +3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.