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Clinical Trials/CTRI/2024/07/071309
CTRI/2024/07/071309Not yet recruitingNot Applicable

Proteomics investigation on the serum samples from diabetic neuropathy patients with vata, pitta and kapha prakriti constitution

Central Council for Research in Ayurvedic Sciences(CCRAS)1 site in 1 country36 target enrollmentStarted: August 4, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
a) A detailed understanding of the serum proteome in blood samples of individual with 3 different prakriti

Study Overview

Brief Summary

Investigating the proteomics in Type 2 Diabetics mellitus and Diabetic Neuropathy(DPN) with in the individual having different Ayurveda prakriti, will help to understand the specific range of different protein and in turn pave the way to development of design for the individual diagnostic tool, prognosis tool, and treatment modality for DPN and diabetic patient. We expand upon those results with integrated, proteomics, to compare the molecular profiles of DPN donors with 3 different prakriti from control donors without diabetes or chronic pain. These results will provide a new insight into changes in the molecular profiles associated with DPN

i.       To generate a comprehensive understanding of the relationship between body types and the risk of developing Diabetics mellitus and Diabetic Neuropathy byselecting control individuals, as well as subjects with DM and DPN based on vata, pitta and kapha individuals

ii.       To evaluate the proteome in blood sera samples of control individuals with three distinct Prakriti constitutions. Specifically, we seek to evaluate the differential protein expression among normal subjects having these different prakriti constitutions.

iii.       To examine the alterations in proteome levels in individuals with DM and DPN who possess varying prakriti constitutions.

iv.       To identify novel biomarkers that can accurately predict the onset and progression of DPN in patients with different constitutions by discovering potential protein markers associated

Study Design

Study Type
Observational

Eligibility Criteria

Ages
30.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • a) Diabetic persons aged between 30-45 years having Hba1c within 6.5% or higher.
  • b) Diabetic subjects with DPN c) Individuals undergone 8 h fasting will be included in the study.
  • d) Diabetic subjects taking only metformin medicine e) Blood samples from females will be collected on the 14 th -18 th day after the first day of last menstrual cycle.

Exclusion Criteria

  • a) Individuals with any comorbidities b) Individuals should not be on any other medication, for any ailments.
  • c) Females under menstruation, lactating and pregnant d) Unwilling participants.

Outcomes

Primary Outcomes

a) A detailed understanding of the serum proteome in blood samples of individual with 3 different prakriti

Time Frame: a) A detailed understanding of the serum proteome in blood samples of individual with 3 different prakriti | will be completed in first year

Secondary Outcomes

  • b) A comprehensive understating of changes in proteome, if any in diabetic subjects with identified constitutions.(c) An inclusive understating of DPN related protein marker in sera samples for the subjects with vata, pitta and kapha constitutions.)

Investigators

Sponsor
Central Council for Research in Ayurvedic Sciences(CCRAS)
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr Niranjana GopalK

Inter University Centre for Biomedical Research and Super Speciality Hospital

Study Sites (1)

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