| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
|
|
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 causesâ€. 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.
|