| CTRI Number |
CTRI/2018/12/016785 [Registered on: 26/12/2018] Trial Registered Prospectively |
| Last Modified On: |
20/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Primary aldosteronism in diabetes and hypertension |
|
Scientific Title of Study
|
Prevalence of primary aldosteronism in patients with type 2 diabetes mellitus and hypertension: Prospective study from western India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tushar Ramkrishna Bandgar |
| Designation |
Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India |
| Phone |
9820025037 |
| Fax |
02224162883 |
| Email |
drtusharb@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tushar Ramkrishna Bandgar |
| Designation |
Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India |
| Phone |
9820025037 |
| Fax |
02224162883 |
| Email |
drtusharb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tushar Ramkrishna Bandgar |
| Designation |
Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India |
| Phone |
9820025037 |
| Fax |
02224162883 |
| Email |
drtusharb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology Funds deposited in Diamond Jubilee Society Trust, Seth GSMC and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Diamond Jubilee Society Trust Seth GSMC and KEM Hospital |
| Address |
Parel, Mumbai - 400012 |
| Type of Sponsor |
Other [Private trust] |
|
|
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 Tushar Bandgar |
KEM Hospital |
Seth G S Medical
College and KEM
Hospital, Parel, Mumbai
- 400012
Mumbai
MAHARASHTRA Mumbai MAHARASHTRA |
9820025037
dtrusharb@gmaill.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with type 2 diabetes mellitus and hypertension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
History of type 2 diabetes
BP 130/80 or on antihypertensives |
|
| ExclusionCriteria |
| Details |
Diabetic ketosis, hyperosmolar non-ketotic syndrome, active infections
• heart failure (New York Heart Association class III or IV)
• Pregnancy, breastfeeding, use of oral contraceptives,
• known primary aldosteronism or a history of pheochromocytoma, Cushing’s syndrome, or hyperthyroidism
• No consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of primary aldosteronism in patients with type 2 diabetes and hypertension |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/12/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Protocol
summary:
Primary aldosteronism (PA) is characterized by
excessive secretion of aldosterone from the adrenal gland. Presence of hyperaldosteronism is associated
with a worse outcome with respect to end organ damage especially faster rate of
progression of proteinuria and adverse cardiovascular outcomes. PA is often
associated impaired glucose tolerance. The contribution of primary
aldosteronism to hypertension in patients with diabetes has not been well
studied. The endocrine society guidelines on management of primary aldosteronism
emphasize that people with hypertension should undergo screening given the
beneficial effect of treatment of PA
The study aims at screening patients with diabetes and
hypertension for primary aldosteronism. All patients with type 2 diabetes attending
the diabetes OPD at KEM hospital will be screened for hypertension. Patients with
diabetes who are already on antihypertensive medications will also be included.
Patients who refuse consent, who have serious infections, diabetic ketosis,
heart failure or another known cause of secondary hypertension will be
excluded. Written informed consent will be taken after ethical clearance. The
identity of participants will be kept confidential and will be coded for
further analysis.
A total of 1000 patients will be screened by using PAC/DRC
ratio as a screening tool. The test involves collection of blood sample after
15 minutes of sitting position. In patients with positive results, further
investigations and treatment as is the standard of care will be provided. This may
include further repeat testing, confirmatory testing, CT adrenals and AVS if
surgical management is planned. Further management either medical or surgical
intervention will be offered to the patients according to guidelines. |