Actively Recruiting
Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
Led by Shanghai 6th People's Hospital · Updated on 2025-09-05
500
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years.
- Diagnosed with difficult to control type 2 diabetes defined by:
- HbA1c between 7.5% and 11.5%, AND taking 3 or more anti-hyperglycemic drugs, OR
- Taking insulin plus other anti-hyperglycemic drugs, OR
- Taking 2 or more anti-hyperglycemic drugs with one or more micro-vascular or macro-vascular complications (such as retinopathy, diabetic nephropathy, chronic kidney disease, diabetic neuropathy, or atherosclerotic heart disease), AND/OR
- Having hypertension requiring 2 or more anti-hypertension medications.
You will not qualify if you...
- Diagnosed with Type 1 diabetes, new-onset diabetes less than 1 year, or other specific diabetes types.
- Used systemic glucocorticoids within the last 3 months (inhaled or topical use allowed).
- Pregnant or breastfeeding.
- Severe dysfunction of heart, liver, kidney, or other major organs.
- Had acute diabetic complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state within the last 3 months.
- Have diseases that significantly affect metabolism, including malignancies or autoimmune disorders.
- Cannot tolerate adhesive tape, have severe skin conditions at sensor sites, or have psychiatric illness or cognitive impairment affecting study compliance.
- Diagnosed with Cushing's syndrome or currently treated with listed medications including mifepristone, metyrapone, and others.
- Excessive alcohol use (more than 14 units per week for men or 7 units per week for women).
- Severe untreated sleep apnea.
- Work night shifts (awake between 11:00 PM and 7:00 AM).
- Known allergy or severe reaction to dexamethasone.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Actively Recruiting
Research Team
J
Jian Zhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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