Home » Trials » SLCTR/2021/015

Effects of meditation on metabolic parameters in patients with type 2 diabetes mellitus


SLCTR Registration Number


Date of Registration

18 Jun 2021

The date of last modification

Jun 21, 2021

Application Summary

Scientific Title of Trial

Effects of meditation on metabolic parameters in patients with type 2 diabetes mellitus

Public Title of Trial

Glycemic control in patients with type 2 diabetes mellitus following mindfulness meditation compared to standard therapy

Disease or Health Condition(s) Studied

Type 2 diabetes mellitus

Scientific Acronym


Public Acronym


Brief title

Effects of meditation on metabolic parameters in patients with type 2 diabetes mellitus

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

EC-19-094 : ERC - University of Colombo

Trial Details

What is the research question being addressed?

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

Type of study


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice




Supportive care

Study Phase

Not Applicable

Intervention(s) planned

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,

Inclusion criteria

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

Exclusion criteria

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

Primary outcome(s)


Glycemic control FBS, HbA1C, Fructosamine


Before intervention and 12 weeks after intervention


Secondary outcome(s)


Lipid profile. Blood pressure. Insulin resistance Autonomic functions assessed by cardiac Autonomic reflex testing (Ewing method) Gut transit time(orocaecal transit time using Hydrogen breath analysis) 24-hour urinary cortisol


Before intervention and 12 weeks after intervention


Target number/sample size

172 (86 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

World Bank AHEAD grant-81

Regulatory approvals

Clinical trial subcommittee of Ethics review committee of Faculty of Medicine, University of Colombo

State of Ethics Review Approval



Date of Approval


Approval number

EC-19-094 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)

Details of Ethics Review Committee

Name: Ethics review committee of the Faculty of Medicine, University of Colombo.
Institutional Address:Faculty of Medicine, No:25, Kinsey road, Colombo 8
Telephone:0112695300 ext240
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. K.P. Chamila Dalpatadu
Senior Lecturer, Department of Physiology, Faculty of Medicine, University of Colombo.
Faculty of Medicine, No 25, Kinsey road, Colombo 8


Contact Person for Public Queries

Dr. K.P. Chamila Dalpatadu
Senior Lecturer, Department of Physiology, Faculty of Medicine, University of Colombo.
Faculty of Medicine, No 25, Kinsey road, Colombo 8


Primary study sponsor/organization

Department of Physiology, Faculty of Medicine, University of Colombo

Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Individual participant data data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be available for sharing. Study protocol will also be available. Data will be available for sharing only after 3 months and ending 36 months following publication. Data will be shared only with researchers who provide methodologically sound proposal. Data will be shared only for meta-analysis. Data will be shared after a written request made to the investigators. Corresponding email address-chamila@physiol.cmb.ac.lk

Study protocol available


Protocol version and date

Effects of meditation on metabolic parameters in patients with type 2 diabetes mellitus Version 3.0: Date 26.10.2020

Protocol URL

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results