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临床试验/CTRI/2025/11/097697
CTRI/2025/11/097697尚未招募3 期

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

Dr E Pandiya Meena1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with Type 2 Diabetes Mellitus FBS, PPBS, HbA1c AS PER ADA Guidelines for type 2 DM Ability to provide informed consent.

排除标准

  • 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.

研究者

发起方
Dr E Pandiya Meena
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

E PANDIYA MEENA

Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute

研究点 (1)

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