Effectiveness of a Yoga-Based Lifestyle Protocol (YLP) in Preventing Diabetes in a High-Risk Indian Cohort: A Multicenter Cluster-Randomized Controlled Trial (NMB-Trial)

Autor: Ilavarasu Judu, Vijaya Majumdar, Hongasandra Ramarao Nagendra, Nagarathna Raghuram, Venkat S. Ram, Amit Singh, Akshay Anand, Jagannadha Rao Basa, Suchitra S. Patil, Srikanta Bhaskara, Rajesh Sk
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Research design
Adult
Blood Glucose
Male
medicine.medical_specialty
Diabetes risk
HbA 1c
Endocrinology
Diabetes and Metabolism
India
030209 endocrinology & metabolism
Type 2 diabetes
prediabetes
Diseases of the endocrine glands. Clinical endocrinology
law.invention
Prediabetic State
03 medical and health sciences
Young Adult
0302 clinical medicine
Endocrinology
Randomized controlled trial
law
Risk Factors
Internal medicine
yoga-based lifestyle intervention
medicine
Humans
Single-Blind Method
030212 general & internal medicine
Prediabetes
Life Style
Original Research
Aged
business.industry
Yoga
Odds ratio
Middle Aged
medicine.disease
RC648-665
Prognosis
Clinical trial
Meditation
Diabetes Mellitus
Type 2
Cohort
Female
type 2 diabetes
business
Risk Reduction Behavior
Biomarkers
Follow-Up Studies
Zdroj: Frontiers in Endocrinology
Frontiers in Endocrinology, Vol 12 (2021)
ISSN: 1664-2392
Popis: IntroductionThough several lines of evidence support the utility of yoga-based interventions in diabetes prevention, most of these studies have been limited by methodological issues, primarily sample size inadequacy. Hence, we tested the effectiveness of yoga-based lifestyle intervention against diabetes risk reduction in multicentre, large community settings of India, through a single-blind cluster-randomized controlled trial, Niyantrita Madhumeha Bharat Abhiyan (NMB). Research Design and MethodsNMB-trial is a multicentre cluster-randomized trial conducted in 80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks)] randomly assigned in a 1:1 ratio to intervention and control groups. Participants were individuals (age, 20–70 years) with prediabetes (blood HbA1c values in the range of 5.7–6.4%) and IDRS ≥ 60. The intervention included the practice of yoga-based lifestyle modification protocol (YLP) for 9 consecutive days, followed by daily home and weekly supervised practices for 3 months. The control cluster received standard of care advice for diabetes prevention. Statistical analyses were performed on an intention-to-treat basis, using available and imputed datasets. The primary outcome was the conversion from prediabetes to diabetes after the YLP intervention of 3 months (diagnosed based upon HbA1c cutoff >6.5%). Secondary outcome included regression to normoglycemia with HbA1c ResultsA total of 3380 (75.96%) participants were followed up at 3 months. At 3 months post-intervention, overall, diabetes developed in 726 (21.44%) participants. YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55–69.85). The YLP also accelerated regression to normoglycemia [adjusted Odds Ratio (adjOR) = 1.20 (95% CI, 1.02–1.43)]. Importantly, younger participants (≤40 years) were found to regress to normoglycemia more effectively than the older participants PinteractionConclusionBased on the significant risk reduction derived from the large sample size, and the carefully designed randomized yoga-based intervention on high-risk populations, the study is a preliminary but strong proof-of-concept for yoga as a potential lifestyle-based treatment to curb the epidemic of diabetes. The observed findings also indicate a potential of YLP for diabetes prevention in low/moderate risk profile individuals that needs large-scale validation.Trial RegistrationClinical Trial Registration Number: CTRI/2018/03/012804.
Databáze: OpenAIRE
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