The Diabetes Remission in India (DiRemI) study: Protocol for a prospective matched-control trial

The global rise in diabetes, particularly in India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural considerations hindering its effective management. Although lifestyle changes have shown promising results, their consistent impleme...

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Published in:PloS one 2024-06, Vol.19 (6), p.e0306394
Main Authors: Tripathi, Pramod, Kadam, Nidhi, Tiwari, Diptika, Kathrikolly, Thejas, Vyawahare, Anagha, Sharma, Baby, Ganla, Malhar, Saboo, Banshi
Format: Article
Language:English
Subjects:
Adult
Aged
Analysis
Anxiety
Body Mass Index
Body size
Body weight
Body weight loss
Clinical trials
Consent
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - psychology
Diabetes Mellitus, Type 2 - therapy
Diabetes therapy
Diet
Drug therapy
Exercise
Female
Gastrointestinal surgery
Health services
Humans
India
Insulin resistance
Intervention
Life Style
Lifestyles
Male
Mental depression
Mental health
Middle Aged
Patients
Physical activity
Physical fitness
Population studies
Prospective Studies
Public health
Questionnaires
Remission
Remission (Medicine)
Remission Induction
Sociodemographics
Thyroid gland
Type 2 diabetes
Weight Loss
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container_title PloS one
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creator Tripathi, Pramod
Kadam, Nidhi
Tiwari, Diptika
Kathrikolly, Thejas
Vyawahare, Anagha
Sharma, Baby
Ganla, Malhar
Saboo, Banshi
description The global rise in diabetes, particularly in India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural considerations hindering its effective management. Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in India, while also considering the unique needs of the Indian population. The DiRemI study is a prospective, open-label, matched-group trial aimed at assessing the impact of a one-year online integrated intensive lifestyle intervention (ILI) comprising dietary modifications, physical activity, psychological support, and medical management on weight loss and remission in adult T2D patients (aged 30-70 years), with a body mass index (BMI) between 25 and 35 kg/m2, and disease duration of
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Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in India, while also considering the unique needs of the Indian population. The DiRemI study is a prospective, open-label, matched-group trial aimed at assessing the impact of a one-year online integrated intensive lifestyle intervention (ILI) comprising dietary modifications, physical activity, psychological support, and medical management on weight loss and remission in adult T2D patients (aged 30-70 years), with a body mass index (BMI) between 25 and 35 kg/m2, and disease duration of &lt;15 years. ILI will be compared with routine medical care (RMC). Participants will be recruited from three clinics: one providing ILI and two others providing RMC. The co-primary outcome will be weight loss and remission at 12 months, with a follow-up at 18 months. The proposed sample size is 360 participants (180 each in intervention and control group). The DiRemI study represents the first large-scale remission study in India to show the effectiveness of an integrated approach in the remission and management of T2D and its complications. The findings of this study hold the potential to report evidence-based strategies for managing T2D both in India and globally, thus alleviating the substantial burden of diabetes on public health systems. 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Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in India, while also considering the unique needs of the Indian population. 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The findings of this study hold the potential to report evidence-based strategies for managing T2D both in India and globally, thus alleviating the substantial burden of diabetes on public health systems. Clinical Trials Registry, India (Registered Number: CTRI/2023/06/053885).</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>38941311</pmid><doi>10.1371/journal.pone.0306394</doi><orcidid>https://orcid.org/0000-0001-8191-272X</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Analysis
Anxiety
Body Mass Index
Body size
Body weight
Body weight loss
Clinical trials
Consent
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - psychology
Diabetes Mellitus, Type 2 - therapy
Diabetes therapy
Diet
Drug therapy
Exercise
Female
Gastrointestinal surgery
Health services
Humans
India
Insulin resistance
Intervention
Life Style
Lifestyles
Male
Mental depression
Mental health
Middle Aged
Patients
Physical activity
Physical fitness
Population studies
Prospective Studies
Public health
Questionnaires
Remission
Remission (Medicine)
Remission Induction
Sociodemographics
Thyroid gland
Type 2 diabetes
Weight Loss
title The Diabetes Remission in India (DiRemI) study: Protocol for a prospective matched-control trial
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