| CTRI Number |
CTRI/2024/03/063793 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Changes in hormonal levels of cortisol and ACTH after taking dexamethasone tablet in the night |
|
Scientific Title of Study
|
ACTH and cortisol dynamics after overnight dexamethasone suppression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version 1.0 dated 10th October 2023 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saba Memon |
| Designation |
Assistant Professor |
| Affiliation |
Seth GSMC and KEMH |
| Address |
Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9971247224 |
| Fax |
|
| Email |
sabasamadmemon@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saba Memon |
| Designation |
Assistant Professor |
| Affiliation |
Seth GSMC and KEMH |
| Address |
Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai
MAHARASHTRA 400012 India |
| Phone |
9971247224 |
| Fax |
|
| Email |
sabasamadmemon@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saba Memon |
| Designation |
Assistant Professor |
| Affiliation |
Seth GSMC and KEMH |
| Address |
Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai
MAHARASHTRA 400012 India |
| Phone |
9971247224 |
| Fax |
|
| Email |
sabasamadmemon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College Multidisciplinary Research Unit |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College Multidisciplinary Research Unit |
| Address |
MRU, 2nd floor, Mortuary Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saba Memon |
Seth GS Medical College and KEM Hospital |
Department of Endocrinology
KEM hospital
Acharya Donde Marg
Parel
Mumbai 400012 Mumbai MAHARASHTRA |
9971247224
sabasamadmemon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Seth GSMC and KEMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cushings |
| Patients |
(1) ICD-10 Condition: K732||Chronic active hepatitis, not elsewhere classified, (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: E243||Ectopic ACTH syndrome, (5) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (6) ICD-10 Condition: E248||Other Cushings syndrome, (7) ICD-10 Condition: E240||Pituitary-dependent Cushings disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diagnostic intervention - Serum hormonal investigations |
Basal ACTH and cortisol will be measured. Repeat ACTH and cortisol will be measured next day at 8AM and 4PM after overnight 1 mg dexamethasone administration at 11PM
Blood testing will be done over 2 days for each study subject |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cushings
Cushings post surgery or radiotherapy
Chronic active hepatitis
Depressive disorder
CKD stage 4 and 5
Women on oral contraceptive pills
Healthy controls |
|
| ExclusionCriteria |
| Details |
Exogenous cushings
Drugs affecting dexamethasone metabolism
Pregnancy and breastfeeding
Acute illness
Liver cirrhosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish normative data of ACTH and cortisol after overnight dexamethasone suppression in various patient groups |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "230"
Final Enrollment numbers achieved (India)="230" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
22/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Endocrine society clinical practice guidelines
recommend use of the 1-mg overnight dexamethasone suppression test (ONDST) to
exclude autonomous cortisol excess and the cutoff suggested for exclusion of
autonomous cortisol secretion in a post-dexamethasone sample is < 50 nmol/L
(< 1.8 ug/dL). ONDST has a very high sensitivity of 98.6% and a specificity
of 90.6%. However,
variable absorption and metabolism of dexamethasone by drugs causing
induction/inhibition of hepatic clearance enzymes may affect the test results. False positive results were also noted in upto 50%
of women taking oral contraceptive pills due to increased CBG levels. Certain psychiatric disorders like depression,
anxiety disorder and obsessive-compulsive disorder are associated with mild
hypercortisolism due to upregulated hypothalamic-pituitary-adrenal (HPA) axis
which may cause abnormal dexamethasone suppressibility and produce false
positive results. Outcome of ONDST may be affected by wide inter-individual
variability in serum dexamethasone concentrations achieved after administration
of 1 mg dexamethasone and hence concurrent serum dexamethasone levels should be measured so that this information
may be taken into consideration when interpreting ONDST results. Dexamethasone
acts by direct suppression of hypothalamic-pituitary-adrenal (HPA) axis. The
suppressed cortisol levels are due to the negative feedback of exogenous
dexamethasone on the hypothalamic and pituitary glucocorticoid receptors which
leads to decreased corticotropin releasing hormone (CRH) and
adreno-corticotropic hormone (ACTH) production respectively. In theory,
measuring ACTH levels rather than cortisol levels in the post-dexamethasone
sample should more accurately reflect the intactness of the HPA axis
regulation. Also, in conditions with alteration in CBG levels leading to
falsely low or high total cortisol values, measuring ACTH after ONDST might
better reflect dexamethasone suppressibility. Data showing ACTH and cortisol
dynamics after ONDST is scarce in the existing literature. Hence, we intend to
establish a normative data for overnight dexamethasone suppressed ACTH and
cortisol levels in various patient groups |