Available online 23 November 2022

Author links open overlay panelAbstractBackground

The pre-diabetic stage is important in terms of identification and timely management due to its reversible nature. Along with other factors, insulin resistance in skeletal muscle is often considered as primary defect before development of overt hyperglycemia and Diabetes Mellitus (DM). Physical exercises are beneficial in prevention of DM by improving skeletal muscle mediated glucose metabolism. Evidence suggests that Yoga interventions appear to be equal and/or superior to exercise in most outcome measures. As the Yogic postures are relatable to exercises, they are considered to improve skeletal muscle function and reverse the pre-diabetic stage.

Methods

This open-labelled, randomized clinical study is planned to evaluate effect of Yoga interventions on muscle mass, strength, endurance and flexibility which are direct/indirect indicators of fat deposition in skeletal muscles. Association between changes in muscle quality/ functionality and glycemic control will also be explored. With ethics committee permission, 120 pre-diabetic individuals of either sex between age group of 35-49 years with BMI range of 25-35 kg/m2 and family history of Type 2 Diabetes Mellitus (T2DM) will be recruited after obtaining written informed consent. They will be randomly allocated to either Yoga or exercise group by computer generated randomized method in a 1:1 ratio. One group will receive defined Yoga interventions, while other group will receive fixed program of physical exercises. Prior to initiating this 12-week study, both groups will undergo a training session for 4 weeks under supervision of a trained instructor. The outcome measures will be parameters related to muscle quality/functionality and glucose metabolism markers.

Discussion

Our study aims to explore practicality of Yoga in pre-diabetic stage on skeletal muscle related glycemic control, which is novel. Additionally, the study will generate awareness about pre-diabetes and provide people with active coping skills for reversing it.

Section snippetsBackground

Rising prevalence of Diabetes Mellitus (DM) is a matter of concern in India & worldwide. [1], [2] A dysglycaemic condition, known as ‘Pre-diabetes’ occurs before manifestation of DM. Pre-diabetes does not exhibit any clinical symptoms and can be identified through various biochemical tests only. [3] If identified and treated properly in this stage, DM progression can be arrested and reversed. It has been reported that, macrovascular complications of DM may start in this pre-diabetes stage

Study design

The present study is an open label, randomized clinical study.

Objectives of the study1.

To evaluate the effect of Yoga interventions on muscle mass, strength, endurance and flexibility which are direct or indirect indicators of fat deposition in skeletal muscles.

2.

To study the association between changes in muscle quality/ functionality and glycemic control.

Study setting

Recruitment of patients, biochemical investigations from serum samples, regular follow up and study documentation will be done at Interactive Research School for

Discussion

The study aims to address one of the most prevalent and detrimental health issues i.e., pre-diabetes. The world staggers with the burden of DM and its complications. Since the pre-diabetic stage is reversible, it becomes pertinent to understand more about its mechanisms and eventually management.

We have planned to test the effect of Yoga on insulin resistance and glucose uptake in skeletal muscles of pre-diabetic individuals. Though earlier studies have proven role of Yoga in achieving glycemic

Ethics approval and consent to participate

The study protocol and consent to participate were reviewed and approved by the Institutional Ethics Committee, Bharati Vidyapeeth Deemed to be University, Pune on 4th March, 2019 (IEC/2019/05). Further, the approval for amendment was received on 6th July, 2019 (IEC/2019/35). A written informed consent will be obtained from all study participants prior to any study related procedures.

Consent for publication

Not Applicable

Dissemination Policy

The study results will be disseminated regardless of magnitude or direction of effect via publications in peer-reviewed journals and updating the trial registry (CTRI) details.

Public access to the data generated

The study is funded by the Government of India and the funding agency will take decision about public access to the data.

Funding

This study is funded by Department of Science & Technology, Government of India under ‘Science and Technology in Yoga and Meditation’ (SATYAM) scheme. The funding agency will be responsible for the monitoring the data only.

Author Statement

The PI will be the corresponding author of publications reporting major as well as minor/ derived outcomes of the study. Other investigators will receive authorship/acknowledgement on the basis of their contribution in actual work and manuscript preparation. Other supporting individuals will be acknowledged with their name and work carried out.

CRediT authorship contribution statement

SB conceived the idea and actively contributed in protocol development; JK gave inputs from Yoga-exercise and physiology perspective and SH drafted the protocol. All authors have read and approved the final manuscript for publication.

Acknowledgements

The authors acknowledge valuable ongoing support of Mrs. Anita Patil, Yoga instructor and Mr. Bapu Borotikar, Yoga expert. We would like to thank the members of Trial Steering Committee; Dr. Vijaya Pandit, Dr. Girish Tillu and Dr. Vaishali Deshmukh. We acknowledge Dr. Vedvati Bhapkar for her help in submitting the manuscript for publication. We thank Dr. Renuka Joshi for her valuable help in language editing of the manuscript.

Competing interests

None Declared

References (26)Demographic and geographic outline of DM,...J. Tripathy et al.Prevalence and risk factors of diabetes in a large community-based study in North India: results from a STEPS survey in Punjab

India. Diabetology & Metabolic Syndrome

(2017)

Nidhi BansalPrediabetes diagnosis and treatment: A review

World journal of diabetes

(2015)

B. Brannick et al.Prediabetes as a toxic environment for the initiation of microvascular and macrovascular complications

Exp Biol Med (Maywood)

(2016 Jun)

A. Ramachandran et al.Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1)

Diabetologia

(2006 Feb)

Francesco Cosentino et al.2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: The Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD)

European Heart Journal

(7 January 2020)

L. Huang et al.Comparisons of different exercise interventions on glycemic control and insulin resistance in prediabetes: a network meta-analysis

BMC Endocr Disord

(2021)

A.J. Rose et al.Skeletal muscle glucose uptake during exercise: how is it regulated?

Physiology (Bethesda)

(2005 Aug)

K.E. Merz et al.Role of Skeletal Muscle in Insulin Resistance and Glucose Uptake

Compr Physiol

(2020)

R. DeFronzo et al.Skeletal Muscle Insulin Resistance Is the Primary Defect in Type 2 Diabetes

Diabetes Care.

(2009)

A. Büssing et al.Effects of Yoga on Mental and Physical Health: A Short Summary of Reviews

Evidence-Based Complementary and Alternative Medicine

(2012)

Yoga is a valuable tool to increase physical activity and decrease noncommunicable disease,...S.M. Chimkode et al.Effect of Yoga on blood glucose levels in patients with type 2 diabetes mellitus

J Clin Diagn Res

(2015)

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