NCT07156370 Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
| NCT ID | NCT07156370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Hypercortisolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18 and 80 years. 2. 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. Exclusion Criteria: 1. Patients with Type 1 diabetes, new-onset diabetes (\<1 year duration), or other specific types of diabetes. 2. History of systemic glucocorticoid use within the last 3 months (inhaled or topical agents are not exclusionary). 3. Pregnant or lactating. 4. Presence of severe cardiac, hepatic, renal, or other major organ dysfunction. 5. History of acute diabetic complications, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, within the last 3 months. 6. Presence of diseases that significantly affect metabolism, such as malignancy or autoimmune disorders. 7. 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. 8. 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. 9. Excessive alcohol consumption (defined as \>14 units per week for males or \>7 units per week for females). 10. Severe, untreated sleep apnea. 11. Night shift workers (defined as being awake between 11:00 PM and 7:00 AM). 12. Known allergy or severe reaction to dexamethasone.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07156370 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypercortisolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07156370 currently recruiting?
Yes, NCT07156370 is actively recruiting participants. Contact the research team at zhoujian@sjtu.edu.cn for enrollment information.
Where is the NCT07156370 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07156370 clinical trial?
NCT07156370 is sponsored by Shanghai 6th People's Hospital. The trial plans to enroll 500 participants.