HypercortisolismNCT07156370
Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
An observational study of Hypercortisolism and Type 2 Diabetes (T2DM), run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to explore the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes despite receiving standard-of-care therapies. Additionally, the study will evaluate the correlation between salivary cortisol levels and glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercortisolism, Type 2 Diabetes (T2DM)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Who may be able to join
- Aged between 18 and 80 years.
- Meets the definition of difficult to control type 2 diabetes:
- HbA1c level between 7.5% and 11.5%, AND Taking 3 or more anti-hyperglycemic drugs. OR Taking insulin and other anti-hyperglycemic drugs. OR Taking 2 or more anti-hyperglycemic drugs AND a.) the presence of 1 or more micro-vascular or macro-vascular complication (retinopathy, diabetic nephropathy and chronic kidney disease, diabetic neuropathy, atherosclerotic heart disease with diabetes); AND/OR b.) concomitant hypertension requiring 2 or more anti-hypertension medications.
Who cannot join
- Patients with Type 1 diabetes, new-onset diabetes (<1 year duration), or other specific types of diabetes.
- History of systemic glucocorticoid use within the last 3 months (inhaled or topical agents are not exclusionary).
- Pregnant or lactating.
- Presence of severe cardiac, hepatic, renal, or other major organ dysfunction.
- History of acute diabetic complications, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, within the last 3 months.
- Presence of diseases that significantly affect metabolism, such as malignancy or autoimmune disorders.
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- Inability to tolerate adhesive tape, severe skin conditions at the sensor placement site, or presence of a psychiatric illness or cognitive impairment that would interfere with study compliance.
- A known diagnosis of Cushing's syndrome, or currently receiving treatment with any of the following: mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, long-acting octreotide, or pasireotide.
- Excessive alcohol consumption (defined as >14 units per week for males or >7 units per week for females).
- Severe, untreated sleep apnea.
- Night shift workers (defined as being awake between 11:00 PM and 7:00 AM).
- Known allergy or severe reaction to dexamethasone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Jiaying Ni, B.S., 021-24056515, njy1997@sjtu.edu.cn
About this study
Official title: Study to Explore the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Assess the Correlation Between Salivary Cortisol and Glucose Levels
The goal of this observational study is to explore the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes despite receiving standard-of-care therapies. Additionally, the study will evaluate the correlation between salivary cortisol levels and glycemic control.
Read the detailed description
Despite advanced treatments, many individuals with type 2 diabetes develop refractory disease, leading to poor glycemic control and a higher risk of complications. Hypercortisolism, which promotes hyperglycemia, may be a key contributing factor. A recent study found a 23.8% prevalence of hypercortisolism in patients with difficult to control type 2 diabetes, linking the condition to higher rates of cardiovascular disease. As stable salivary cortisol testing can effectively screen for this condition, this study has two aims. First, the study will evaluate the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and identify its associated risk factors. Second, the study will establish the correlation between salivary cortisol and glycemic levels in this population.
- Conditions
- Hypercortisolism, Type 2 Diabetes (T2DM)
- Medical subject headings
- Cushing Syndrome, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hypercortisolism
Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) >1.8 μg/dL in patients with difficult to control type 2 diabetes, defined as HbA1c 7.5-11.5%, despite receiving standard-of-care therapies.
Measured: Baseline (Screening)
Secondary outcomes (2)
Correlation between salivary cortisol and glycemic levels
Correlation between salivary cortisol and glycemic levels, including hemoglobin A1c, glycated ablumin, 1,5-anhydroglucitol and metrics derived from continuous glucose monitoring.
Measured: One week
Levels of salivary cortisol
Levels of salivary cortisol in patients with difficult to control type 2 diabetes measured by fluorescence immunoassay system
Measured: 8:00, 16:00, 23:00, and 8:00 on the following day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start11 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercortisolismStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156370
- Sponsor's protocol ID
- 20250810
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Explore the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Assess the Correlation Between Salivary Cortisol and Glucose Levels
- ClinicalTrials.gov ID
- NCT07156370
- Acronym / sponsor ID
- 20250810
- Conditions
- Hypercortisolism, Type 2 Diabetes (T2DM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
The goal of this observational study is to explore the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes despite receiving standard-of-care therapies. Additionally, the study will evaluate the correlation between salivary cortisol levels and glycemic control.
Detailed description
Despite advanced treatments, many individuals with type 2 diabetes develop refractory disease, leading to poor glycemic control and a higher risk of complications. Hypercortisolism, which promotes hyperglycemia, may be a key contributing factor. A recent study found a 23.8% prevalence of hypercortisolism in patients with difficult to control type 2 diabetes, linking the condition to higher rates of cardiovascular disease. As stable salivary cortisol testing can effectively screen for this condition, this study has two aims. First, the study will evaluate the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and identify its associated risk factors. Second, the study will establish the correlation between salivary cortisol and glycemic levels in this population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Key inclusion criteria (3 listed)
- Aged between 18 and 80 years.
- Meets the definition of difficult to control type 2 diabetes:
- HbA1c level between 7.5% and 11.5%, AND Taking 3 or more anti-hyperglycemic drugs. OR Taking insulin and other anti-hyperglycemic drugs. OR Taking 2 or more anti-hyperglycemic drugs AND a.) the presence of 1 or more micro-vascular or macro-vascular complication (retinopathy, diabetic nephropathy and chronic kidney disease, diabetic neuropathy, atherosclerotic heart disease with diabetes); AND/OR b.) concomitant hypertension requiring 2 or more anti-hypertension medications.
Key exclusion criteria (12 listed)
- Patients with Type 1 diabetes, new-onset diabetes (<1 year duration), or other specific types of diabetes.
- History of systemic glucocorticoid use within the last 3 months (inhaled or topical agents are not exclusionary).
- Pregnant or lactating.
- Presence of severe cardiac, hepatic, renal, or other major organ dysfunction.
- History of acute diabetic complications, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Hypercortisolism
Time frame: Baseline (Screening)
Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) >1.8 μg/dL in patients with difficult to control type 2 diabetes, defined as HbA1c 7.5-11.5%, despite receiving standard-of-care therapies.
2 secondary outcomes
Correlation between salivary cortisol and glycemic levels
Time frame: One week
Levels of salivary cortisol
Time frame: 8:00, 16:00, 23:00, and 8:00 on the following day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Hypercortisolism and Type 2 Diabetes (T2DM), run by Shanghai 6th People's Hospital at 1 site in China.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhou (+86-021-64369181, zhoujian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hypercortisolism (time frame: Baseline (Screening)). 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 27 Jul 2026.