NCT07873320Enrolling by invitation
Prevalence and Predictors of Hypercorticolism in Patients With Difficult to Control Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
Type 2 diabetes mellitus (T2DM) is a major global health burden, affecting approximately 589 million adults worldwide in 2024, with the number projected to reach 853 million by 2050 .Despite advances in glucose-lowering therapy, a substantial proportion of patients remain inadequately controlled despite multiple medications . Hypercortisolism is a potentially reversible contributor to poor glycemic control. Excess cortisol promotes hepatic gluconeogenesis, impairs peripheral insulin sensitivity, and adversely affects β-cell function, thereby contributing to insulin resistance and hyperglycemia .Clinical manifestations of Cushing syndrome may overlap with common features of T2DM and obesity, making mild or clinically unapparent hypercortisolism difficult to recognize . Recent evidence has highlighted the relevance of hypercortisolism in patients with difficult-to-control T2DM. In the multicenter CATALYST study, 23.8% of 1,057 participants with inadequately controlled T2DM had an abnormal 1-mg dexamethasone suppression test (DST), defined as post-DST cortisol \>1.8 µg/dL (50 nmol/L) . However, data regarding the prevalence and clinical characteristics of hypercortisolism among Egyptian patients with difficult-to-control T2DM are lacking. The Endocrine Society recommends biochemical testing for suspected Cushing syndrome using validated first-line tests, including the 1-mg overnight DST, late-night salivary cortisol, or urinary free cortisol .Therefore, determining the prevalence and characteristics of hypercortisolism in difficult-to-control T2DM may help identify a potentially treatable contributor to persistent hyperglycemia and provide locally relevant evidence for clinical practice.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 290 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- 30 Aug 2026
- Primary completion date
- 29 Oct 2028
- Lead sponsor
- Assiut University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07873320
What you commit to
- Study type: Observational
- Planned participants: 290
- From 30 Aug 2026 to the primary completion date, 29 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent use \<3 months of systemic glucocorticoids, estrogens, oral contraceptives, or drugs affecting cortisol metabolism like ketoconazole, rifampin, phenytoin. Topical/inhaled steroids \<500 mcg/day beclomethasone equivalent are allowed.
- Known diagnosis of Cushing's syndrome, adrenal tumor, or pituitary disease previously diagnosed.
Other illness
- Type 1 DM or any other specific types of diabetes.
- Acute illness, infection, or hospitalization \<1 month- cause stress hypercortisolism.
Lab values
- Severe hepatic failure,Child-Pugh C, or severe renal failure, eGFR \<30 ml/min/1.73m² - affect cortisol metabolism.
Other
- Pregnancy or lactation- due to physiological hypercortisolism.
- Alcohol abuse\* \>3 units/day for males, \>2 units/day for females.
- Inability to understand study procedures or give consent.
- Depression
Who the study is looking for
- \- Age: Adults ≥18 years and ≤70 years.
- \- Diagnosis: Confirmed Type 2 Diabetes Mellitus ≥2 years duration according to ADA criteria.
- 3- Definition of Difficult-to-Control T2DM: HbA1c ≥8.5% on two separate measurements ≥3 months apart, despite adherence to ≥3 antidiabetic medications including basal insulin ≥0.5 IU/kg/day for a minimum of 6 months.
- 4- Treatment adherence: Confirmed medication adherence and proper insulin injection technique by clinical assessment + pharmacy refill records 5- Willingness: Signed informed consent to participate in the study and undergo 1mg DST + confirmatory tests
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut University hospital Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.