Status:
RECRUITING
Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Hypercortisolism
Type 2 Diabetes (T2DM)
Eligibility:
All Genders
18-80 years
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. Additional...
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 hyp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07156370
Start Date
September 1 2025
End Date
December 31 2027
Last Update
September 5 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, China, 200233