Salivary Cortisol and Hypercortisolism in Type 2 Diabetes

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL ·

Keywords

ClinConnect Summary

This is an observational study in Shanghai, China, trying to understand how common high cortisol levels are in adults with difficult-to-control type 2 diabetes and whether saliva cortisol levels relate to blood sugar control. About 500 adults will be enrolled, and researchers will collect saliva samples at specific times and perform a cortisol test to see if cortisol is unusually high. This study is not testing a treatment; it’s just observing and measuring things to learn more about the link between cortisol and diabetes. Primary results will look at how many people have hypercortisolism (a cortisol problem) and how saliva cortisol lines up with measures of blood sugar, such as A1c and other sugar tests.

Who can participate? Adults aged 18 to 80 with type 2 diabetes that remains hard to control, defined as an HbA1c between 7.5% and 11.5% despite using multiple diabetes medicines (or insulin with other therapies), and with certain cardiovascular or blood pressure issues. There are several exclusions, including type 1 diabetes, recent use of systemic steroids, pregnancy, significant organ problems, recent severe diabetic emergencies, and other conditions that could affect cortisol testing. If eligible, you’ll undergo baseline testing, including saliva cortisol measurements at several times and a test to assess how your body handles cortisol, along with collection of routine diabetes control data. The study is overseen by a safety committee and is not a drug or device trial.

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Eligibility criteria