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Introduction

Diabetes mellitus (DM) is an emerging epidemic that has a collective impact on almost every country and age group across the world. Type 1 DM is an autoimmune disorder causing insulin deficiency due to β-cell destruction, while Type 2 DM results from insulin resistance or deficiency. Complications are common among people with diabetes (90% globally)¹ , and increase health risks and cause considerable morbidity and mortality.²

The chronic state of hyperglycaemia leads to nonenzymatic glycation, which in turn causes microvascular and macrovascular complications, with microvascular pathology being more prevalent than macrovascular.³ Microvascular complications include neuropathy, nephropathy and retinopathy, while cardiovascular disease, stroke, and peripheral artery disease (PAD) are due to macrovascular complications.⁴ Diabetic foot syndrome, the presence of foot ulcers associated with neuropathy, PAD and infection, is a major cause of lower limb amputation.^5,6 The duration of diabetes acts as an independent biomarker for increased risk of cardiovascular disorders.⁶ Peripheral neuropathy is the most common complication of both Type 1 and Type 2 DM.⁷ Such vascular complications lead to structural changes in the brain and decrements in mental flexibility and cognitive function. There is no established treatment for brain pathology associated with diabetes apart from improving glycaemic control.⁸

Lifestyle intervention contributes an estimated 60% more reduction in complications compared to anti-diabetic medication alone.⁹ Naturopathy is a traditional healthcare profession defined by its philosophies, principles, and theories. Naturopathic care is diverse, multi-modal, and provides individualised care using a wide range of therapies and practices.¹⁰ Yoga is considered a mind-body therapy with demonstrated favorable effects on physical and emotional health, and may improve physical, psychological and emotional fitness in people with diabetes.¹¹ Yoga and naturopathic lifestyles regulate blood sugar levels in both pre-diabetic and diabetic individuals, which can control and prevent complications of Type 2 DM. ^12,13

Maintaining glycaemic control is crucial to avoid both macro- and micro-vascular complications. Glycaemic control refers to fasting plasma blood glucose concentrations being within the normal range (3.9-5.5mmol/L) in patients with DM. For individuals with Type 2 DM, glycaemic control can be evaluated using three parameters: glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial glucose (PPG). Identifying the factors that influence glycemic control is essential to prevent associated complications.¹⁴

Reaction time (RT) is an assessment of cognitive and psychomotor speed and function. It measures the time interval between stimulus (signal onset) and movement response. Reaction speed in humans is a direct indicator of nerve transmission and skeletal muscular innervation, as nerves located in the central nervous system transmit impulses to muscles via peripheral nerves that are measured in milliseconds.^15,16 Reaction time serves as an objective measure of both peripheral nerve conduction and central cognitive processing speed,¹⁷ and reflects the speed of central information processing and the coordination of movement responses. Extended reaction time is a marker of cognitive decline and potential neurodegenerative conditions.^18,19

DM can cause damage to peripheral nerves, impair psychomotor reactions, and lead to cognitive consequences in individuals with poor metabolic control. Over time, autonomic dysfunction in people with Type 2 DM can slow reflexes, resulting in longer reaction times to various external stimuli.²⁰ Auditory reaction time (ART) is an assessment of the time between auditory perception and skeletal muscle reaction, sensorimotor integration, and attention, and quantifies the neurocognitive effects of interventions.²¹

There are minimal studies evaluating yoga and naturopathy for nerve conduction in people with diabetes. Hence, this study aims to evaluate the effectiveness of yoga and naturopathy, in addition to conventional medical care, against conventional medical care alone, on neurological and cognitive functions and glycaemic control in people with diabetes.

Materials and methods

Subjects

This single-centre randomised controlled study recruited participants from the inpatient department of Yoga and Nature Cure Hospital, Karnataka, India. Patients with medically diagnosed diabetes, meeting the American Diabetes Association (ADA) definition of diabetes, of any gender or body weight, were invited to participate in the study. People using psychoactive substances, sedatives, anxiolytics and anti-depressants were excluded. Sixty people aged between 30 and 60 years met the inclusion criteria and were randomly assigned to one of two groups; yoga and naturopathy plus standard medical care or standard medical care alone (Figure 1).

 

*YNLI-Yoga and Naturopathy Lifestyle intervention

Figure 1. Illustration of trial profile

 

This experiment was carried out under the Code of Ethics of the World Medical Association (Declaration of Helsinki) for a study involving humans and is registered in the Clinical Trials Registry-India (CTRI/2024/01/061898). The study protocol was approved by the institutional ethical committee. Pre and post-data were collected at two time points on the first day and after 10 days, as shown in Figure 1. The five-minute ART and sugar profile data were assessed before and after the ten-day intervention phase.

The test group received yoga and naturopathy lifestyle intervention(YNLI) including a combination of therapeutic fasting and low-calorie diet, mud therapy, hydrotherapy, manipulative therapy and an integrated yoga program composed of asanas, pranayama, meditation, relaxation techniques, kriyas, and yoga-based counselling sessions, along with conventional medical care (Table 1 and Table 2), and the control group received only conventional management of standard medical care for 10 days (Figure 1). Standard medical care consisted of healthy dietary practices and oral hypoglycaemic pharmaceuticals, including biguanides and sulfonylureas.

 

Table 1. Naturopathic intervention

 

Table 2. Participant characteristics at baseline.

 

Participants were categorised as: 1. diet alone, 2. diet plus one pharmaceutical agent, or 3. diet plus two or more pharmaceutical agents.

Previous investigations of yoga and naturopathy in people with diabetes have not identified any serious adverse reactions or events; however, participants were advised to report any adverse reactions or effects of the interventions to the study coordinators. Each participant provided formal written consent.

 

Figure 2. Yoga protocol for 10 days

 

Sample size

Based on the literature review, the sample size was calculated by G^* power version 3.1.9.7 software with effect size 0.8, ɑ=0.05, power (1-ß error)=0.92, n=60 using an independent t-test.²² The randomisation schedule was generated using the Quantum random number generator. Participants were allocated to one of two groups at a 1:1 ratio.

Biochemical investigations

Biochemical investigations were conducted at the Central Lab of the institute, where blood was drawn by a healthcare professional from an antecubital vein. Fasting blood glucose (FBG) was assessed eight hours after the last meal in a sterile vacutainer, and estimated using the hexokinase method. Postprandial blood sugar (PPBG) was estimated by the glucose oxidase peroxide method, undertaken within two hours after the meal. Blood glucose was evaluated before and after the study period.

Reaction time

Auditory reaction time (ART) was measured using an AD Instrument’s 8-channel polygraph, and the waveforms will be analysed using LabChart Pro software.

ART acts as a non-invasive surrogate marker to measure sensorimotor integration and cognitive processing speed in response to a particular auditory stimulus. The subjects were seated in a relaxed state with closed eyes and with headphones for an auditory beep-tone stimulus in a soundproof room to avoid artifact sounds. Participants were asked to release the response key immediately upon perceiving the stimulus. Four recordings were made immediately following the click-tone stimulus. Segments 1 and 2 present the stimuli at pseudorandom intervals ranging from one to ten seconds. Segments 3 and 4 present the stimuli at fixed intervals of four seconds.

Data analysis

The Statistical Package for the Social Sciences (SPSS) by IBM, USA, was used for the statistical analysis (Version 21.0). The Kolmogorov-Smirnov test assessed the normal distribution. The pre-test and post-test scores of ART (seconds), FBS (mg/Dl), and PPBS (mg/Dl) in cases and controls follow normal distribution. Within-group over time and between-group comparisons at endpoint were assessed with paired and unpaired t-tests, respectively. A two-tailed p-value less than 0.005 was considered statistically significant, because regression to the mean in the secondary outcomes wasn’t accounted for in the sample size calculation, we applied a Bonferroni correction for secondary outcomes and set statistical significance at p=0.001.

Results

Participants’ characteristics are presented in Table 2. There were no significant differences between the groups at baseline, Table 2.

At 10 days, a significant difference in ART (p-value<0.001) with a mean difference (MD) of 0.10 seconds ± 0.08 was found in the YNLI group, representing a percentage reduction of 15.77%. On the other hand, the control group did not show a significant difference in ART over time (MD 0.0± 0.09, 1.58%, p value=0.550). The difference between the two groups at ten days was 0.12 seconds ± 0.09, which was statistically significant p<0.01 and is shown in Figure 3 and Table 3.

 

**p<0.01, *p<0.05, YNLi Group

Figure 3. Pretest and post-test ART (sec) scores in both groups

 

Table 3. Reaction time and glycaemic levels within and between groups

 

Fasting blood glucose and post-prandial blood glucose were comparatively different between the groups by day 10 (Figure 4). Specifically, the FBG levels in the YNLI group showed a mean difference of 43.53 mgDl ± 43.46 (25.49% change) from the baseline, while the control group had a MD of 1.03± 3.03 (0.62% change), (p=0.07).

 

**p<0.01, *p<0.05, YNLI Group

Figure 4. Pretest and posttest FBS (MG/DL) scores in both groups

 

PPBG levels in the YNLI group exhibited a MD of 47.03 ±48.44 (23.06%) from the baseline, while the control group had a mean difference of 0.60 ±4.48 (0.32% change, p=0.47), as shown in Table 3 and Figure 5.

 

**p<0.01, *p<0.05, YNLI-Yoga and Naturopathy Lifestyle intervention

Figure 5. Pretest and posttest  PPBS (MG/DL) scores

 

Discussion

This study demonstrates the effectiveness of additional yoga and naturopathy to standard medical care for improving neurological sensitivity and response time in people with DM. The study found significant improvements in auditory reaction time and glycemic control after yoga and naturopathy treatments in addition to standard medical care compared to standard medical care alone. These results align with previous research and elucidate the correlation between glycaemic control and macromolecular and microvascular complications in diabetes.²³ An increase in reaction time is documented and may be due to the slowing of conduction velocity in peripheral nerves, coupled with central neuraxis involvement.

This study supports the positive neurological effects of yoga and naturopathy in people with diabetes.^24–26 The findings of the present study included people with DM, where there is an established body of evidence demonstrating delayed auditory and visual reaction times associated with uncontrolled glycaemia. Delayed neurological response in people with diabetes may be due to persistent elevated HbA1c and consequential microvascular damage, causing peripheral nerve complications.^27,28 There is a significant relationship between the reaction time and glycaemic indices, and reaction time can be taken as a sensitive indicator for the severity of nerve damage before the clinical manifestation of diabetic neuropathy.²⁷

While long-standing Type 2 DM can affect peripheral nerves, slow the psychomotor responses and contribute to cognitive deficits. Psychomotor responses may also affect peripheral nerves in the somatosensory system, including reaction time to auditory and visual stimulation.^28,29

Prolonged hyperglycemia is associated with damage to the blood-brain barrier (BBB), which has been linked to cognitive impairment. Diabetic patients demonstrate compromised BBB integrity compared to non-diabetic controls.³⁰ Hyperglycemia promotes the formation of reactive oxygen species (ROS), triggering the production of inflammatory mediators, including interleukin-6 (IL-6) and C-reactive protein. These cytokines have the potential to induce damage to cerebral vesicles, contributing to the structural deterioration of the BBB, which in turn correlates with the progression of cognitive dysfunction.^26,31,32

Sustained hyperglycaemia generates free radicals, nitrosative stressors, and oxidative stress and is a risk factor for developing peripheral neuropathy in people with diabetes. Metabolic dysregulation can increase the polyol pathway flux and increase the formation of advanced glycation end products, cytokine release and protein kinase C activation, impeding vascular nerve supply. The result is hypoxic damage to nerve cells. Long-term hyperglycemia is a critical determinant of peripheral nerve damage. In our study, the improvements were found in reaction time to auditory stimulation, along with improvements in glycaemic parameters for the yoga and naturopathic interventions.^33–35 People with long-standing diabetes are at increased risk of microvascularity disease, impaired neural responses, and motor nerve conduction velocity.^28,36,37 According to Zheng M et al (2019)³⁸, a case-control study of 126 individuals with Type 2 DM shows that the pervasive inflammatory condition significantly contributes to the development of cognitive decline.

Studies indicate that adopting a healthy lifestyle, notably incorporating regular exercise, reduces pro-inflammatory mediators, including C-reactive protein (CRP), and improves cognitive function.^38,39 Various meta-analysis studies on yoga and lifestyle modifications show that improved glycaemic control is achieved by reducing HbA1c and blood sugar levels.⁴⁰ In the present study, a yoga- and naturopathy-based lifestyle intervention, with a focus on detoxification and involvement of the mind-body complex, resulted in better glycaemic control compared to standard treatment alone. This finding was also supported by Kyizom and Singh, who found that yoga therapy, when combined with conventional medical treatment, also resulted in improved blood glucose control.^40-42 These positive effects of yoga and naturopathy may be due to the synergy of multiple components of these complex interventions.^43,44

Future directions and limitations

The study was limited by the small sample size and recruitment from a single site in India, results may not be generalisable to other populations and settings. Although the interventions were defined, the self-reporting nature of dietary intake and lifestyle practices is at risk of self-reporting bias. Differences between the groups may remain undocumented and undermine the reliability of the findings of this study. In addition, the study was not blinded, and motivation and participation in standard medical care may be inaccurately reported. Further research with a large sample size and RCT rigorous design is needed to substantiate the findings of this study. These trials could include correlation analyses of the outcomes assessed. Additional relevant outcomes include evaluations of the mechanisms of therapeutic effect, such as oxidative stress, biomarker assays, extended nerve conduction tests, inflammatory markers, and heart rate variability, would contribute to understanding of the auto regulatory mechanisms involved in to better understand the autoregulatory mechanisms involved in nerve repair.

Conclusion

This present study indicates that a yoga and naturopathy lifestyle intervention (YNLI) has positive effects on neural response and glycaemic control in Type 2 DM. These findings indicate that YNLI may enhance standard medical care; however, RCTs with larger sample sizes, conducted over longer time frames, are needed to build on these results.

Conflict of interest

There is no conflict of interest during the study.

Funding

None

Authors’ Contributions

MU was involved in conceptualisation, methodology, collecting the data, resources, data curation, and writing the original draft; AVR was involved in methodology, formal analysis, reviewingthe manuscript and editing, data curation and supervision.; SS was involved in conceptualisation, methodology, and supervision. SHC was involved in methodology, writing, review, editing and supervision.

Author(s)

Udhayalakshmi¹, Valsakumar Rajalatha Abitone*², Shivaprasad Shetty³, Shashikiran^4
1Department of Clinical Yoga, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka, India
²Department of Anatomy, SDM college of Naturopathy and Yogic Sciences, Ujire, Karnataka, India
³Department of Clinical Yoga, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka, India
⁴Department of Research, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka, India

*Corresponding author email dr.abitone@yahoo.com  (ORCID 0000-0002-9795-3208)

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