| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
|
|
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. ‘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. |