Using salivary cortisol to detect hidden cortisol excess in adults with hard-to-control Type 2 diabetes

Study to Explore the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Assess the Correlation Between Salivary Cortisol and Glucose Levels

This will test whether a simple salivary cortisol test can find hidden cortisol excess in adults whose Type 2 diabetes is hard to control.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07156370 on ClinicalTrials.gov

What this trial studies

This observational study will enroll adults aged 18–80 with difficult-to-control Type 2 diabetes and collect salivary cortisol samples to screen for hypercortisolism. Investigators will record HbA1c, medication regimens, presence of micro- or macrovascular complications, and antihypertensive use to define participant clinical status. The primary aim is to determine the prevalence of hypercortisolism and associated risk factors in this population, and the secondary aim is to correlate salivary cortisol levels with measures of glycemic control. No interventional treatment is assigned; results will inform whether routine salivary screening could explain or help manage refractory hyperglycemia.

Who should consider this trial

Good fit: Adults 18–80 with Type 2 diabetes that remains hard to control (HbA1c 7.5–11.5% plus use of multiple glucose-lowering medications or insulin and/or diabetes complications or hypertension requiring multiple drugs) are ideal candidates.

Not a fit: People with Type 1 diabetes, new-onset diabetes (<1 year), recent systemic glucocorticoid use, pregnancy or lactation, or severe organ dysfunction are excluded and unlikely to benefit from this screening.

Why it matters

Potential benefit: If successful, routine salivary cortisol screening could identify treatable hypercortisolism and potentially improve blood sugar control and reduce complications for affected patients.

How similar studies have performed: Prior work has reported about a 23.8% prevalence of hypercortisolism in similar hard-to-control diabetes populations and suggests salivary cortisol is a practical screening tool, though findings are not yet widely validated.

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.

Where this trial is running

Shanghai

• Shanghai Sixth People's Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jian Zhou

Conditions: Hypercortisolism, Type 2 Diabetes