Salivary Cortisol and Hypercortisolism in Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai 6th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 80 years.
Disqualifiers
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.
Trial population
The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of Hypercortisolism
Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) \>1.8 μg/dL in patients with difficult to control type 2 diabetes, defined as HbA1c 7.5-11.5%, despite receiving standard-of-care therapies.
Time frame
Baseline (Screening)Secondary outcomes
1
Correlation between salivary cortisol and glycemic levels
Correlation between salivary cortisol and glycemic levels, including hemoglobin A1c, glycated ablumin, 1,5-anhydroglucitol and metrics derived from continuous glucose monitoring.
Time frame
One week2
Levels of salivary cortisol
Levels of salivary cortisol in patients with difficult to control type 2 diabetes measured by fluorescence immunoassay system
Time frame
8:00, 16:00, 23:00, and 8:00 on the following daySponsors and contacts
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Source ClinicalTrials.gov