What is the effect of mindfulness meditation on the glycemic control in patients with type2 diabetes mellitus who are on oral hypoglycemic drugs?

Patients are selected from the University medical clinic of the National Hospital of Sri Lanka. Patients will be screened for inclusion and exclusion criteria and once informed written consent is obtained randomization will be done using an online random number generation program. Block randomization will be done in blocks of 10. According to the number allocated they will be assigned to either intervention or waitlisted group. Patients in the intervention group will continue to receive standard therapy in addition to following the mindfulness meditation program. Standard therapy includes monthly clinic visits, review of fasting blood glucose (FBS)/HbA1C, continuation of oral hypoglycemic drugs and medication review, dietary and life style advice, annual screening for retinopathy and neuropathy if it falls during the period of study. Patients will undergo other investigations according to the need. Mindfulness Meditation program is for a period of 3 months. This program is based on Buddhist teaching but the actual program does not have any content of the Buddhist preaching nor will they be asked to restrict normal pattern of behaviour. Aim is for the participants to practice mindfulness (keeping the attention in the present moment) techniques and achieve a state of calmness and relaxation of the mind. Patients will be expected to attend initially once a week 45-60 minutes sessions at the Department of Physiology, Faculty of Medicine, Colombo for 12 weeks where mindfulness meditation will be taught. • The techniques used in this mindfulness meditation program are not complex techniques. Participants will be asked to first walk for 5 minutes keeping the attention only to the feet/sensation of the feet. If they get distracted they are expected to again focus on the present moment that is walking. Following simple techniques will be taught. • They will be asked to sit on a chair mindfully (focusing on the posture of the body) for 10 minutes. • In Mindful breathing they will be asked to focus the attention on to the tip of the nose or the chest where they can feel their breath while quietly breathing. • They will be asked to focus the attention to the feel of the breath calmly and to feel inhalation and exhalation of breath for 15-20 minutes. • Several other techniques to focus attention will be also will be taught practiced. Examples listening to a bell, mindful eating • After each session the instructor (who is trained on meditation) will individually talk to the participants and ask them to describe the mindfulness meditation technique they learnt and clarify any questions. During the interview with the instructor they will be assessed with regards to understanding of the technique and if they were mindful while practicing mindfulness meditation. • Once weekly sessions will be held for batches of 20 participants in the Department of Physiology,

I. Age between 18 and 75 years II. Willingness to participate for a meditation program III. Commitment to adhere to the program for 3 months. IV. Diagnosed with type 2 Diabetes mellitus within the past 3-5 years. V. Patients taking two or less than two anti-diabetic medications VI. HbA1C between 7 and 8% VII. Education level secondary level and above (Grade 8 and above) VIII. Montreal cognitive assessment score more than 26/30

i. Type 1 diabetes ii. Long term meditators/experienced meditators (Long term experienced meditators are defined as those who have been practicing meditation at least for the last three years including those who participate in regular weekly formal meditation sessions and those who regularly self practice meditation six hours per week or more.) iii. Hemoglobinopathy (Patients with Thalassemia/sickle cell disease/sickle-thalassemia, abnormal hemoglobin (HbE,HbS, HbC)) that can interfere with HbA1C monitoring. iv. Renal impairment (Estimated GFR less than 60mL/min/1.73m2) v. Any malignancy vi. Any other chronic disorders (ex. thyroid disease) vii. Patients on steroids, insulin, beta blockers, calcium channel blockers cisapride, domperidone, other anti-arrhythmic medication, antidepressants, antihistamineand sympathomimetic cough preparations26 viii. Alcohol abuse or use of neurotoxic medication ix. History of post traumatic stress disorder, epilepsy, depression or psychosis. x. Diagnosed autonomic dysfunction or peripheral neuropathy. xi. Presence of acute illness and severe systemic disease xii. Angina pectoris xiii. Congestive heart failure NYHA Class III-IV xiv. Diagnosed cardiac arrhythmia xv. Myocardial infarction or invasive cardiovascular procedure within the past six months. xvi. Stroke in last 6 months xvii. Patients with chronic diarrhoea xviii. Patients who are unable to attend weekly meditation sessions xix. Patients not consenting for meditation xx. Montreal cognitive assessment score of less than 26/30