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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with type 2 diabetes mellitus and hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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