| CTRI Number |
CTRI/2025/11/097697 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TYPE 2 DIABETES MELLITUS AND PRION PROTEINS |
|
Scientific Title of Study
|
CO-RELATION OF AMYLIN AND AMYLOID FIBRILS WITH TYPE 2 DIABETES MELLITUS AND ITS ASSOCIATION WITH PRION PROTEINS AND LOW DOSE DOXYCYCLINE ROLE IN LOWERING THE GLYCEMIC INDEX - AN UNICENTRIC, DOUBLE BLINDED, RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E PANDIYA MEENA |
| Designation |
Assistant Professor |
| Affiliation |
Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute |
| Address |
Department of General medicine, Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
7824051677 |
| Fax |
|
| Email |
epandiyameena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Madhan Jeyaraman |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute |
| Address |
Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8310600785 |
| Fax |
|
| Email |
madhanjeyaraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Madhan Jeyaraman |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute |
| Address |
Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8310600785 |
| Fax |
|
| Email |
madhanjeyaraman@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr E Pandiya Meena |
| Address |
Dept of General Medicine, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Chennai |
| 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 |
| Dr Madhan Jeyaraman |
Faculty of Medicine - Sri Lalithambigai Medical college and Hospital |
Department of General Medicine Sri Lalithambigai Medical College and Hospital
Adayalampattu, Maduravoyal.
Chennai
TAMIL NADU |
8310600785
madhanjeyaraman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of Medicine - Sri Lalithambigai Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline |
T2 DM with doxycycline 500 mg twice daily for 1 month |
| Comparator Agent |
Without doxycycline |
T2 DM without doxycycline |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Type 2 Diabetes Mellitus
FBS, PPBS, HbA1c AS PER ADA Guidelines for type 2 DM
Ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Presence of type 1 diabetes or gestational diabetes
Severe renal insufficiency
Uncontrolled cardiovascular disease or neurodegenerative disorder
Pregnant or breast feeding woman
Other autoimmune disorder
Amyloidosis other than IAPP |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between amylin levels and amyloid fibril deposition in the pancreas |
On day 0, and end of 1, 2, 3, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glycemic control
C-peptide levels
Prion proteins |
At the end of 6 and 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This unicentric, double-blinded randomized controlled trial investigates the correlation between amylin levels, amyloid fibril deposition, and prion protein involvement in Type 2 Diabetes Mellitus (T2DM). Amylin, co-secreted with insulin, forms toxic amyloid fibrils in pancreatic beta cells, contributing to cell dysfunction. The study explores prion-like behavior in amylin aggregation, suggesting a mechanistic link to neurodegenerative diseases. It also evaluates the therapeutic potential of low-dose doxycycline in reducing systemic inflammation and improving glycemic control. Participants aged 25–55 with T2DM will undergo biochemical assessments including serum amylin, urinary amyloid fibrils, inflammatory markers, and prion protein expression. The trial aims to identify novel biomarkers and therapeutic targets to enhance beta-cell function and glycemic regulation. Ethical protocols, informed consent, and adverse event monitoring are integral to the study. Ultimately, the research seeks to advance understanding of T2DM pathogenesis and offer innovative strategies for diagnosis and personalized treatment. |