Salivary Cortisol and Hypercortisolism in Type 2 Diabetes

NCT07156370 | Recruiting DMC

• 1 other identifier: 20250810
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercortisolism; Type 2 Diabetes (T2DM)

Outcome Measures

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.

  Baseline (Screening)

Secondary Outcomes (2)

• Correlation between salivary cortisol and glycemic levels

  One week

• Levels of salivary cortisol

  8:00, 16:00, 23:00, and 8:00 on the following day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.

You may qualify if:

• Aged between 18 and 80 years.
• 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.

You may not qualify if:

• Patients with Type 1 diabetes, new-onset diabetes (\<1 year duration), or other specific types of diabetes.
• Pregnant or lactating.
• Presence of severe cardiac, hepatic, renal, or other major organ dysfunction.
• History of acute diabetic complications, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, within the last 3 months.
• Presence of diseases that significantly affect metabolism, such as malignancy or autoimmune disorders.
• 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.
• 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.
• Excessive alcohol consumption (defined as \>14 units per week for males or \>7 units per week for females).
• Severe, untreated sleep apnea.
• Night shift workers (defined as being awake between 11:00 PM and 7:00 AM).
• Known allergy or severe reaction to dexamethasone.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

RECRUITING

MeSH Terms

Conditions

Cushing Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jian Zhou

CONTACT

+86-021-64369181; zhoujian@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Chief Physician, Deputy Director

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)