ObesityACICNCT01156519
Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)
A study testing Salivary Cortisol in people with Obesity, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Salivary Cortisol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients (≥18 years)
- Signed informed consent
- Subjects affiliated with an appropriate social security system
- Body mass index above 30 kg/m2 and
- Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm)
Who cannot join
- Pregnancy
- Sepsis
- Recent surgery (less than 30 days)
- Any recent severe acute conditions requiring hospitalisation (less than 30 days)
- Recent use (< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration
- Long-term oral corticosteroids
- Nicotinic substitute or per os licorice in 2 weeks before the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects
- Conditions
- Obesity
- Being tested
- Salivary Cortisol
- Keywords
- Infra-clinic cortisol adenoma, Salivary cortisol, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary CortisolOther
- Day 1: 1st salivary cortisol at 23 hours
- Day 2: 2nd salivary cortisol at 23 hours and administration of dexamethasone (for overnight 1-mg dexamethasone suppression test)
- Day 3: serum cortisol at 8 am
- Between Day 4 and Month 3: if serum cortisol at 8 am > 18ng/mL:
- Cortisol for 24 hours
- dexamethasone suppression test (2mg/j during 2 days)
- Cortisol and ACTH cycle
- Noriodocholesterol scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Salivary cortisol | Other | Not described Receives: Other: Salivary Cortisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test as the reference method for the detection of ACIC in obese subjects
Secondary outcomes (5)
Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
To evaluate specificity, negative predictive value, positive predictive value and diagnostic accuracy of salivary cortisol compared to serum cortisol at 8 am after overnight 1-mg dexamethasone suppression test
Comparing the results of salivary cortisol dosage and serum cortisol dosage
To evaluate concordance between salivary cortisol dosage and serum cortisol dosage
Comparing the results of the two salivary samples
To evaluate the concordance of the two salivary samples
Number of patients with metabolic complications of obesity among patients with ACIC
To evaluate the link between ACIC and metabolic complications of obesity (insulin resistance, IFG, type 2 diabetes, NAFLD…)
Number of patients with severe type 2 diabetes among patients with ACIC
To evaluate the relationship between ACIC and severity of type 2 diabetes, if established.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionMar 2014
Why it stopped: Number of patients with a serum cortisol \> 18 ng/ml reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand CARIOU, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156519
- Sponsor's protocol ID
- 09/12-I
- Acronym
- ACIC
- Status last verified
- Jul 2014
- First submitted
- 29 Jun 2010
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
- ClinicalTrials.gov ID
- NCT01156519
- Acronym / sponsor ID
- ACIC / 09/12-I
- Conditions
- Obesity
- Keywords
- Infra-clinic cortisol adenoma, Salivary cortisol, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of patients with a serum cortisol \> 18 ng/ml reached
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Jul 2010 (estimated)
- 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.
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salivary cortisol | Other | Other: Salivary Cortisol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years)
- Signed informed consent
- Subjects affiliated with an appropriate social security system
- Body mass index above 30 kg/m2 and
- Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm)
Key exclusion criteria (7 listed)
- Pregnancy
- Sepsis
- Recent surgery (less than 30 days)
- Any recent severe acute conditions requiring hospitalisation (less than 30 days)
- Recent use (< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration
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 |
|---|---|---|
| Salivary Cortisol* Day 1: 1st salivary cortisol at 23 hours * Day 2: 2nd salivary cortisol at 23 hours and administration of dexamethasone (for overnight 1-mg dexamethasone suppression test) * Day 3: serum cortisol at 8 am * Between Day 4 and Month 3: if serum cortisol at 8 am > 18ng/mL: * Cortisol for 24 hours * dexamethasone suppression test (2mg/j during 2 days) * Cortisol and ACTH cycle * Noriodocholesterol scintigraphy | Other | Salivary cortisol |
Primary outcome
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test as the reference method for the detection of ACIC in obese subjects
5 secondary outcomes
Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
Comparing the results of salivary cortisol dosage and serum cortisol dosage
Comparing the results of the two salivary samples
Number of patients with metabolic complications of obesity among patients with ACIC
Number of patients with severe type 2 diabetes among patients with ACIC
Results and safety
The study was stopped early (reason given: Number of patients with a serum cortisol \> 18 ng/ml reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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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.
Bertrand CARIOU, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salivary Cortisol in people with Obesity, run by Nantes University Hospital at 1 site in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Jul 2014. 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 France. 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 was stopped early (reason given: Number of patients with a serum cortisol \> 18 ng/ml reached). Results are not available in the source record.
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?
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2014.