ClinicalTrials.gg
CompletedNCT03458533CHIASMUpdated Dec 6, 2022

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

An observational study in Overweight and Obesity and Metabolic Syndrome, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-06.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Roma La Sapienza · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
69
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Obesity by University of Roma La Sapienza — 3 open to participants now, 4 under way, none of them phase 3. Obesity · University of Roma La Sapienza.

Started
2016
with 1 other
Observational
8 of 25
1 open now
Registered
10th of 25
by date

Among the 25 studies in Obesity by University of Roma La Sapienza, this one is one of 2 that started in 2016, is one of 8 observational ones, and was the 10th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

3 of the 25 studies in Obesity by University of Roma La Sapienza are open now, in 6 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Obesity by University of Roma La Sapienza, or all of them as a file.
02

Study 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)

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:

  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
03

Conditions studied

  • Overweight and Obesity
  • Metabolic Syndrome

Browse trials for

Keywords

  • Pituitary
  • Obesity
  • Overweight
  • Metabolic syndrome
  • MRI
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 69 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 25 Kg/m2

Exclusion criteria

Exclusion Criteria:

  • Malignant neoplasia;
  • Current use of psychotropic drugs;
  • Chronic renal failure;
  • Pituitary macroadenomas and craniopharyngiomas;
  • to MRI execution (p. e. pace-maker, metal foreign bodies like slivers, non MRI compatible vascular clips or prosthesis)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
69 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group 1

    Obese patients with indication to bariatric surgery

    Procedure: Bariatric surgery

  • 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

  • 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

Interventions

  • ProcedureBariatric surgery

    Also known as: sleeve gastrectomy, gastric bypass, bilio-intestinal bypass

  • BehavioralDiet and lifestyle changes

    Also known as: hypocaloric diet, physical exercise

07

What researchers measure

Primary outcomes

  1. Pituitary volume

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

    Time frame: 0, +3 years

Secondary outcomes

  1. Evaluation of pituitary mean and standard deviation intensity

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

    Time frame: 0, +3 years

  2. Correlation of magnetic resonance parameters with anthropometric measurements

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

    Time frame: 0, +3 years

  3. Correlation of magnetic resonance parameters with pituitary axis function

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

    Time frame: 0, +3 years

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

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

    Time frame: 0, +3 years

08

Study locations

1 site
  • Andrea M Isidori
    Rome, 00161, Italy
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Jun 2020, 43 months.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 43 months is close to that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 8, 2018
StartActual
Nov 2016
Primary completionActual
Jun 30, 2020
CompletionActual
Jun 30, 2020
Last update
Dec 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03458533
Responsible party
Andrea M. Isidori (MD, PhD, University of Roma La Sapienza) — Principal investigator
First posted
Mar 8, 2018
Start date
Nov 2016
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Dec 6, 2022

Study contacts

Andrea M Isidori, MD, PhD
principal investigator · University of Roma La Sapienza

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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