An observational study in Detect the Prevalence, sponsored by Assiut University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Assiut University · Observational
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.
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.
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Age: Adults ≥18 years and ≤70 years. Diagnosis: Confirmed Type 2 Diabetes Mellitus ≥2 years duration according to ADA criteria.
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.
Treatment adherence: Confirmed medication adherence and proper insulin injection technique by clinical assessment + pharmacy refill records Willingness: Signed informed consent to participate in the study and undergo 1mg DST + confirmatory tests
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
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 \[1\]. Despite advances in glucose-lowering therapy, a substantial proportion of patients remain inadequately controlled despite multiple medications \[2\]. 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 \[3,4\]. Clinical manifestations of Cushing syndrome may overlap with common features of T2DM and obesity, making mild or clinically unapparent hypercortisolism difficult to recognize \[4\]. 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
Diagnostic Test: Over night dexamethasone suppression test
Overnight dexamethasone suppression test
Also known as: 24 urinary free cortisol
Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes mellitus
Percentage of participants with difficult-to-control type 2 diabetes mellitus who meet the predefined diagnostic criteria for hypercortisolism, based on the results of the 1-mg overnight dexamethasone suppression test (ONDST). Unit of Measure:Percentage (%)
Time frame: Baseline
Predictors of hypercortisolism in patients with difficult-to-control type 2 diabetes mellitus
Association of baseline clinical and biochemical characteristics, including age, sex, body mass index, duration of diabetes mellitus, glycated hemoglobin (HbA1c), blood pressure, lipid profile, and insulin therapy, with the presence of hypercortisolism as determined by the 1-mg overnight dexamethasone suppression test. Unit of Measure:Odds ratio
Time frame: Baseline
Clinical and biochemical predictors of hypercortisolism in patients with difficult-to-control type 2 diabetes mellitus
Association between the presence of hypercortisolism and baseline clinical and biochemical characteristics, including age, sex, body mass index, duration of diabetes mellitus, glycated hemoglobin (HbA1c), blood pressure, and lipid profile. Unit of Measure:Odds ratio
Time frame: Baseline
Plan to share: Yes — 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 [1]. Despite advances in glucose-lowering therapy, a substantial proportion of patients remain inadequately controlled despite multiple medications [2]. 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 [3,4]. Clinical manifestations of Cushing syndrome may overlap with common features of T2DM and obesity, making mild or clinically unapparent hypercortisolism difficult to recognize [4]. 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
Supporting information: Study protocol
Time frame: From 29 /9/2026 to 30/10/2028
Access criteria: Other researchers after publication of the study
Started Aug 2026 (actual). Primary completion is estimated for Oct 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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