Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-17
Brief Title:
LCMD for Type 2 Diabetes Remission Evaluation of Effectiveness and Exploration of Individual Differences
Sponsor:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Organization:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Low-Calorie Medicinal Diet for Type 2 Diabetes Remission Evaluation of Effectiveness and Exploration of Individual Differences
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LCMD
Brief Summary:
Type 2 diabetes T2DM has become a major public health problem Achieving remission HbA1c65 without glucose-lowering medications has recently become a new treatment goal Low-calorie diets effectively induce remission but adverse effects like fatigue appetite and constipation hinder success Integrating traditional Chinese medicine TCM herbs into a low-calorie diet may alleviate adverse effects and improve remission rates
This project investigates the efficacy of a Low-Calorie Medicine Diet LCMD in achieving T2DM remission among overweightobese individuals through a randomized controlled trial The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms focusing on the brain-gut-microbiota axis By integrating nutrition and TCM dietetics this project provides a novel evidence-based approach to managing T2DM in Chinese populations
This project investigates the efficacy of a Low-Calorie Medicine Diet LCMD in achieving T2DM remission among overweightobese individuals through a randomized controlled trial The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms focusing on the brain-gut-microbiota axis By integrating nutrition and TCM dietetics this project provides a novel evidence-based approach to managing T2DM in Chinese populations
Detailed Description:
Type 2 diabetes T2DM has become a major public health problem and effective prevention and treatment strategies are urgently needed Recently the understanding of T2DM has shifted to a disease that can be remission Achieving remission defined as HbA1c65 without using glucose-lowering medications has become a new treatment goal for T2DM Evidence suggests that a low-calorie diet is an effective approach to induce remission Our previous research NCT05472272 also demonstrated that a low-calorie diet can achieve remission in Chinese T2DM patients
However adverse effects during the intervention such as fatigue appetite and constipation have become significant barriers to successful remission These symptoms often result in poor adherence to the intervention plan and consequently failure to achieve remission In traditional Chinese medicine TCM fatigue and constipation are typical symptoms of Qi Vacuity while hunger is more associated with Yin Vacuity Herb is the food is a unique concept in TCM Integrating TCM herbs into a low-calorie diet may help alleviate these adverse effects and improve the likelihood of achieving diabetes remission
This project aims to investigate the efficacy of a Low-Calorie Medicine Diet LCMD in achieving remission of T2DM among overweightobese individuals through a randomized controlled trial The investigators will also explore individual differences in achieving remission and elucidate the underlying biological mechanisms focusing on the brain-gut-microbiota axis By integrating theories from nutrition and TCM dietetics this project seeks to provide a novel evidence-based approach to the management of T2DM in Chinese populations
However adverse effects during the intervention such as fatigue appetite and constipation have become significant barriers to successful remission These symptoms often result in poor adherence to the intervention plan and consequently failure to achieve remission In traditional Chinese medicine TCM fatigue and constipation are typical symptoms of Qi Vacuity while hunger is more associated with Yin Vacuity Herb is the food is a unique concept in TCM Integrating TCM herbs into a low-calorie diet may help alleviate these adverse effects and improve the likelihood of achieving diabetes remission
This project aims to investigate the efficacy of a Low-Calorie Medicine Diet LCMD in achieving remission of T2DM among overweightobese individuals through a randomized controlled trial The investigators will also explore individual differences in achieving remission and elucidate the underlying biological mechanisms focusing on the brain-gut-microbiota axis By integrating theories from nutrition and TCM dietetics this project seeks to provide a novel evidence-based approach to the management of T2DM in Chinese populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None