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CTRI Number  CTRI/2019/01/017120 [Registered on: 17/01/2019] Trial Registered Prospectively
Last Modified On: 11/01/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on complications of diabetes and risk of heart attack 
Scientific Title of Study   Study on Diabetic microvascular complications and CAD using Mass spectroscopy based proteomics and metabolomics. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr K Neelaveni 
Designation  Professor (Endocrinology) 
Affiliation  Osmania Medical College 
Address  Department of Endocrinology. Osmania Medical College Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India

Hyderabad
TELANGANA
500012
India 
Phone  9848131182  
Fax    
Email  neelaveni1@yahoo.co.in  
 
Source of Monetary or Material Support  
Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India  
 
Primary Sponsor  
Name  Osmania Medical College 
Address  Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India  
Type of Sponsor  Government medical college 
 
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 K Neelaveni  Osmania Medical College  Osmania General Hospital, Afzalgunj,Hyderabad -500012 Telangana, India
Hyderabad
TELANGANA 
9848131182

neelaveni1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee,   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Pre diabetic patients, type2 diabetes with and without complications will be included 
 
ExclusionCriteria 
Details  Type1 diabetes
Patients not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To search for the biomarkers for early diagnosis and prognostic purpose in Diabetic vascular complications using proteomics and metabolomics as a tool.  At the time of recruitment of participant in the study 
 
Secondary Outcome  
Outcome  TimePoints 
• Establishment of Biomarker for early diagnostic of Diabetes / CAD / diabetic complications using body fluids especially serum/plasma, urine by the help of high resolution mass spectrometry and quantitative proteomics and metabolomics.

• Metabolomics biomarker: small molecules, amino acid, carbohydrate, lipid and peptide


• Proteomics Biomarker: Protein


• Validation of biomarker of Diabetes (and its complication) / CAD using Western blot and qPCR.
 
At the time of recruitment of participant in the study 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/01/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes mellitus is a complex metabolic disorder that is associated with insulin resistance, impaired insulin signaling, b-cell dysfunction, abnormal glucose levels, altered lipid metabolism, subclinical inflammation and increased oxidative stress . Diabetes mellitus has become a major global health problem with almost 415 million people affected in 2015, and a projected figure of 642 million by 2040 (International Diabetes Federation). Type 2 diabetes mellitus leads to long-term vascular complications, including micro- and macrovascular complications, such as peripheral neuropathy, retinopathy, nephropathy, CAD  with decreased quality of life and increased mortality . There is no cure once the disease is diagnosed, but early treatment at the subclinical stage can prevent or at least halt disease progression. Thus, it is of critical importance to diagnose these complications at the earliest to reduce the morbidity and mortality. 

Metabolomics is a systems biology approach that provides global metabolic information about biological samples. It has been widely used in the diagnosis and treatment of diabetes . Many studies have shown elevated plasma levels of branched-chain amino acids and their derivatives, aromatic amino acids, and a-hydroxybutyrate before the manifestation of type 2 diabetes mellitus . However, studies of diabetic complications are scarce.

 â€˜Proteome’ is used to describe the entire protein complement of a system and ‘proteomics’ is the study of this complement. Proteins are the principal mediators of every cellular process, and the proteome of an organism is far more complex than its genome. Consequently, it is more informative. The genome remains stable throughout life and the genome isolated from one cell type is (for the most part) identical to that isolated from another. Thus, the genome cannot provide information regarding the impact of environmental and other stimuli on a particular organism or cell. The high throughput mass spectrometry based proteomics has helped in unveiling the identification and mapping of signaling networks associated with the post-translational modifications (PTMs) along with changes in the expression of proteins

spectrometry based proteomics has helped in unveiling the identification and mapping of signaling networks associated with the post-translational modifications (PTMs) along with changes in the expression of proteins

 There are limited proteomics-metabolomics based studies to date in the field of diabetes,especially with regard to complications in India. Hence there is a need for such studies to find out  biomarkers  which can help us in diagnosing the diabetic complications early so that appropriate preventive and treatment strategies can be instituted.      

The purpose of the study is to identify the  marker using the quantitative proteomic approaches which includes label and label free approaches and to find out how the signaling cascade mechanisms, metabolites and post translational mechanisms responsible for the conversion of diabetes to diabetic complications stage.

 
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