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CTRI Number  CTRI/2019/08/020983 [Registered on: 30/08/2019] Trial Registered Prospectively
Last Modified On: 26/08/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Autonomic Neuropathy in Type 2 Diabetes Mellitus  
Scientific Title of Study   Understanding Autonomic Neuropathy in Type 2 Diabetes Mellitus – A Prospective Observational Study in Patients Attending Outpatient Clinics of Tertiary Care Hospitals  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaustav Saha 
Designation  Post Doctoral Trainee 
Affiliation  School of Tropical Medicine Kolkata 
Address  Third Floor Dept of Clinical and Experimental Pharmacology School of Tropical Medicine

Kolkata
WEST BENGAL
700073
India 
Phone  7980527795  
Fax    
Email  kaustavsh37@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Santanu Kumar Tripathi 
Designation  Professor 
Affiliation  School of Tropical Medicine Kolkata 
Address  Third Floor Dept of Clinical and Experimental Pharmacology School of Tropical Medicine

Kolkata
WEST BENGAL
700073
India 
Phone  9230566771  
Fax    
Email  tripathi.santanu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kaustav Saha 
Designation  Post Doctoral Trainee 
Affiliation  School of Tropical Medicine Kolkata 
Address  Third Floor Dept of Clinical and Experimental Pharmacology School of Tropical Medicine

Kolkata
WEST BENGAL
700073
India 
Phone  7980527795  
Fax    
Email  kaustavsh37@gmail.com  
 
Source of Monetary or Material Support  
Self Dr Kaustav Saha Department of Clinical and Experimental Pharmacology School of Tropical Medicine Kolkata 
 
Primary Sponsor  
Name  Kaustav Saha 
Address  Third Floor Dept of Clinical and Experimental Pharmacology School of Tropical Medicine Kolkata 
Type of Sponsor  Other [Self] 
 
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 
Kaustav Saha  School of Tropical Medicine Kolkata  Room no 19 Dept of Clinical and Experimental Pharmacology School of Tropical Medicine Kolkata
Kolkata
WEST BENGAL 
7980527795

kaustavsh37@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Research Ethics Committee School of Tropical Medicine Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult diabetic patients
2. Patients of either gender
3. Ambulatory patients
4. Willingness to participate by signing consent form
 
 
ExclusionCriteria 
Details  1. Not willing to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Autonomic neuropathy tests
2. Glycaemic Control in terms of HbA1C, FBG, PPPG
3. Microvascular complications
4. Macrovascular complications
5. Medication adherence
6. Lifestyle modifications

 
1. At Baseline
2. 6 months
3. 12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Basic demographics
2. Comorbidities
3. Screening for nasal symptoms, sweating disturbances, postural fall / dizziness, gastrointestinal symptoms (diarrhoea, constipation, discomfort/ pain) headache, micturition disturbances, impotence, occasional attack of bronchospasm, neuropathic abnormalities.
4. Risk Factors screening for family history of alcoholism, diabetes mellitus, CHD, obesity, smoking  
1. At Baseline
2. 6 months
3. 12 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/09/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Diabetic autonomic neuropathy (DAN) is a serious and often underestimated complication of diabetes. Due to its ability to potentially affect any tract of autonomic nervous system, DAN is a systemic-wide disorder, which encompasses a large spectrum of organs and leads to significant increase in morbidity and mortality. Subclinical DAN can occur within a year of diagnosis in T2DM and within 2 years in T1DM, while first symptoms may onset after years.The most common and studied manifestation of DAN is cardiovascular autonomic neuropathy (CAN), owing to its life-threatening complications (arrhythmias, silent myocardial ischemia, and sudden death) and to its relation with other microangiopathic comorbidities.  Diabetic neuropathy is classically defined as “the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes”.  Sensory, motor, or autonomic nerves can be involved, often coexisting.The reported prevalence of DAN varies widely depending on the cohort studied and the methods of assessment. In randomly selected cohorts of asymptomatic individuals with diabetes, ∼20% had abnormal cardiovascular autonomic function. DAN frequently coexists with other peripheral neuropathies and other diabetic complications, but DAN may be isolated, frequently preceding the detection of other complications. DAN may affect many organ systems throughout the body (e.g., gastrointestinal [GI], genitourinary, and cardiovascular). Major clinical manifestations of DAN include resting tachycardia, exercise intolerance, orthostatic hypotension, constipation, gastroparesis, erectile dysfunction, sudomotor dysfunction, impaired neurovascular function, “brittle diabetes,” and hypoglycemic autonomic failure.

However, studies probing autonomic neuropathy dysfunctions in diabetic patients in Indian scenario are scare. Addressing this dearth, the present prospective observational study has been planned to understand autonomic neurodeficit in a cohort of type 2 diabetes mellitus (T2DM) patients attending the outpatient department of a tertiary care hospital.

 
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