Using salivary cortisol to detect hidden cortisol excess in adults with hard-to-control Type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults aged 18–80 with difficult-to-control Type 2 diabetes and collect salivary cortisol samples to screen for hypercortisolism. Investigators will record HbA1c, medication regimens, presence of micro- or macrovascular complications, and antihypertensive use to define participant clinical status. The primary aim is to determine the prevalence of hypercortisolism and associated risk factors in this population, and the secondary aim is to correlate salivary cortisol levels with measures of glycemic control. No interventional treatment is assigned; results will inform whether routine salivary screening could explain or help manage refractory hyperglycemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 18 and 80 years.
2. Meets the definition of difficult to control type 2 diabetes:

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:

1. Patients with Type 1 diabetes, new-onset diabetes (\<1 year duration), or other specific types of diabetes.
2. History of systemic glucocorticoid use within the last 3 months (inhaled or topical agents are not exclusionary).
3. Pregnant or lactating.
4. Presence of severe cardiac, hepatic, renal, or other major organ dysfunction.
5. History of acute diabetic complications, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, within the last 3 months.
6. Presence of diseases that significantly affect metabolism, such as malignancy or autoimmune disorders.
7. Inability to tolerate adhesive tape, severe skin conditions at the sensor placement site, or presence of a psychiatric illness or cognitive impairment that would interfere with study compliance.
8. A known diagnosis of Cushing's syndrome, or currently receiving treatment with any of the following: mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, long-acting octreotide, or pasireotide.
9. Excessive alcohol consumption (defined as \>14 units per week for males or \>7 units per week for females).
10. Severe, untreated sleep apnea.
11. Night shift workers (defined as being awake between 11:00 PM and 7:00 AM).
12. Known allergy or severe reaction to dexamethasone.

Where it's running

• Shanghai Sixth People's Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jian Zhou
• Email: zhoujian@sjtu.edu.cn
• Phone: +86-021-64369181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pancreatin Added to Standard Diabetes Therapy

  Researchers are testing whether adding pancreatin helps people with type 2 diabetes see better blood sugar control when they already take oral meds or insulin.

  Recruiting Phase 4 Silesian Centre for Heart Diseases · Zabrze, Silesian Voivodeship · NCT07852988

• BGM0504 vs. semaglutide in Chinese adults with obesity-related T2DM

  In Chinese adults with type 2 diabetes and obesity who aren’t well controlled by diet and exercise, this trial tests BGM0504 injections once a week for 52 weeks against semaglutide to see which helps more with blood sugar, weight, and safety, including whether diabetes stays in remission after stopping treatment.

  Recruiting Phase 3 BrightGene Bio-Medical Technology Co., Ltd. · Nanjing, Jiangsu · NCT07743983

• Health for Hungary: Long-term blood and health data collection to study aging and disease onset

  This study tests whether routine blood tests plus advanced molecular analyses can help detect the early stages of non-communicable diseases in adults over 40.

  Recruiting at 21 sites Center for Molecular Fingerprinting Research Nonprofit LLC · Balatonfüred and 32 other locations · NCT07743021

• Real-Time Glucose Monitoring in Newly Diagnosed Type 2 Diabetes

  This study tests whether real-time glucose monitoring helps people with newly diagnosed type 2 diabetes manage glucose better than traditional finger-prick testing.

  Recruiting at 2 sites Bogomolets National Medical University · Kyiv and 2 other locations · NCT07690163

• Cinematic virtual reality to improve geriatric care training for osteopathic medical students.

  This project will test whether cinematic virtual reality training helps osteopathic medical students learn geriatric care better than traditional lectures.

  Recruiting Ohio University · Athens, Ohio · NCT07542834

• GZR33 Injection plus Insulin Degludec for Type 2 Diabetes in Need of More Control

  This study tests whether daily GZR33 injection plus daily Insulin Degludec can help adults with type 2 diabetes who aren’t adequately controlled by pills.

  Recruiting Phase 3 Gan & Lee Pharmaceuticals. · Beijing · NCT07527078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.