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Detect the PrevalenceNCT07873320

Prevalence and Predictors of Hypercorticolism in Patients With Difficult to Control Type 2 Diabetes Mellitus

An observational study of Detect the Prevalence, run by Assiut University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Detect the Prevalence
What is being tested?
Over night dexamethasone suppression test
How many people
290 participants
Where
1 siteEgypt
Study dates
30 Aug 2026to 30 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • - 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

Who cannot join

  • Type 1 DM or any other specific types of diabetes.
  • Pregnancy or lactation- due to physiological hypercortisolism.
  • 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.
  • Severe hepatic failure,Child-Pugh C, or severe renal failure, eGFR <30 ml/min/1.73m² - affect cortisol metabolism.
  • Acute illness, infection, or hospitalization <1 month- cause stress hypercortisolism.
Show all 9Show fewer
  • Alcohol abuse* >3 units/day for males, >2 units/day for females.
  • Inability to understand study procedures or give consent.
  • Depression

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Assiut university hospital

    Asyut, Asyut Governorate, Assiut

Other trials in Egypt

About this study

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 .

Read more

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.

Read the detailed description

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.

Being tested
Over night dexamethasone suppression test
Keywords
Detect the prevalence and predictors of Hypercorticolism in patients with difficult to control type 2 diabetes mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Over night dexamethasone suppression testDiagnostic test

    Also called 24 urinary free cortisol

    Overnight dexamethasone suppression test

Study groups in NCT07873320
Study groupRoleWhat they receive
Patients with difficult to control type 2 diabetesType 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
Receives: Diagnostic Test: Over night dexamethasone suppression test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (%)

    Measured: Baseline

Secondary outcomes (1)
  1. 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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study start30 Aug 2026
  3. Primary completion29 Oct 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07873320
Sponsor's protocol ID
Prevalence of Hypercorticolism
Status last verified
Oct 2026
First submitted
30 Sep 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Publications

  • Buse JB, Kahn SE, Aroda VR, Auchus RJ, Bailey T, Bancos I, Busch RS, Christofides EA, DeFronzo RA, Eilerman B, Findling JW, Fonseca V, Hamidi O, Handelsman Y, Miller HJ, Ownby JG, Parker JC, Philis-Tsimikas A, Pratley R, Rosenstock J, Shanik MH, Sloan LL, Umpierrez G, Tudor IC, Schlafly TK, Einhorn D; CATALYST Investigators*. Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes. Diabetes Care. 2025 Dec 1;48(12):2012-2020. doi: 10.2337/dc24-2841.

    PubMed 40249765
  • Nieman LK, Biller BM, Findling JW, Newell-Price J, Savage MO, Stewart PM, Montori VM. The diagnosis of Cushing's syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2008 May;93(5):1526-40. doi: 10.1210/jc.2008-0125. Epub 2008 Mar 11.

    PubMed 18334580
  • Geer EB, Islam J, Buettner C. Mechanisms of glucocorticoid-induced insulin resistance: focus on adipose tissue function and lipid metabolism. Endocrinol Metab Clin North Am. 2014 Mar;43(1):75-102. doi: 10.1016/j.ecl.2013.10.005.

    PubMed 24582093

Questions about this trial

What is this clinical trial studying?

An observational study of Detect the Prevalence, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes mellitus (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07873320, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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