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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.
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 hyperglycemia, may be a key contributing factor. A recent study found a 23.8% prevalence of hypercortisolism in patients with difficult to control type 2 diabetes, linking the condition to higher rates of cardiovascular disease. As stable salivary cortisol testing can effectively screen for this condition, this study has two aims. First, the study will evaluate the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and identify its associated risk factors. Second, the study will establish the correlation between salivary cortisol and glycemic levels in this population.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Screening) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week |
| Levels of salivary cortisol |
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Inclusion Criteria:
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 Criteria:
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The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou | Contact | +86-021-64369181 | zhoujian@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Recruiting | Shanghai | 200233 | China |
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| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
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Levels of salivary cortisol in patients with difficult to control type 2 diabetes measured by fluorescence immunoassay system |
| 8:00, 16:00, 23:00, and 8:00 on the following day |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |