Actively Recruiting
Study to Explore the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Assess the Correlation Between Salivary Cortisol and Glucose Levels
Led by Shanghai 6th People's Hospital · Updated on 2025-09-05
500
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the prevalence of hypercortisolism, a condition that may worsen blood sugar control, among people with difficult to control type 2 diabetes despite receiving standard treatments. The study aims to identify risk factors linked to hypercortisolism and examine how salivary cortisol levels relate to blood sugar control in this group. This observational study is sponsored by Shanghai 6th People's Hospital and seeks to better understand factors contributing to poor diabetes management and related cardiovascular risks. Participants will be adults aged 18 to 80 years with type 2 diabetes that is hard to manage, defined by specific criteria including elevated HbA1c levels and use of multiple diabetes medications or insulin, possibly combined with complications or hypertension. The study involves collecting saliva samples at specific times of the day to measure cortisol levels and monitoring blood sugar levels. There are no experimental treatments or interventions; instead, data will be observed and analyzed to assess the correlations. Participants will provide saliva samples at 8:00 AM, 4:00 PM, 11:00 PM, and the following morning at 8:00 AM. The study will measure the prevalence of hypercortisolism at the start and evaluate the relationship between cortisol and blood sugar over one week. Researchers will also collect data on glycemic control, complications, and medications. The total duration and follow-up depend on participant availability, focusing on observational data collection without direct treatment changes.
CONDITIONS
Brief 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%.
- Taking three or more anti-hyperglycemic drugs, or insulin with other anti-hyperglycemic drugs.
- Having one or more diabetes-related complications such as retinopathy, nephropathy, chronic kidney disease, neuropathy, or atherosclerotic heart disease.
- Or having hypertension requiring two or more anti-hypertensive medications.
You will not qualify if you...
- Type 1 diabetes, new-onset diabetes (less than 1 year), or other specific diabetes types.
- Use of systemic glucocorticoids within the last 3 months (inhaled or topical steroids allowed).
- Pregnant or breastfeeding.
- Severe cardiac, liver, kidney, or other major organ dysfunction.
- Recent acute diabetic complications like ketoacidosis or hyperosmolar hyperglycemic state within 3 months.
- Diseases significantly affecting metabolism such as cancer or autoimmune disorders.
- Unable to tolerate adhesive tape, severe skin conditions at sensor sites, psychiatric illness, or cognitive impairment affecting compliance.
- Known Cushing's syndrome or treatment with certain cortisol-related drugs.
- Excessive alcohol consumption exceeding defined weekly limits.
- Severe untreated sleep apnea.
- Night shift workers awake between 11:00 PM and 7:00 AM.
- Allergy or severe reaction to dexamethasone.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants provide salivary samples at specified times to assess cortisol levels and their correlation with glucose levels.
Saliva collection at 8:00, 16:00, 23:00, and 8:00 on the following day
Duration - Up to 6 months
Participants are observed to evaluate the prevalence of hypercortisolism and related risk factors in type 2 diabetes.
Additional assessments may occur depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Actively Recruiting
Research Team
J
Jian Zhou
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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