Effects of meditation on physiological and metabolic parameters in patients with type 2 diabetes mellitus "MindDM": study protocol for a randomized controlled trial.
K P C Dalpatadu, P Galappatthy, P Katulanda, S Jayasinghe
Trials September 30, 2022 DOI: 10.1186/s13063-022-06771-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (open-label, waitlist-controlled; study protocol) Peer reviewed |
|---|---|
| Sample size | 172 |
| Population | Patients attending the professorial unit medical clinic with type 2 diabetes mellitus who have never meditated or rarely meditated (less than once every three months) |
| Intervention | usual care |
| Duration | 12-week intervention; outcomes assessed at baseline and after 3 months |
| Measures | HbA1c, fasting blood sugar, fructosamine, insulin resistance (calculated using fasting serum insulin), 24-h urinary cortisol, body mass index, cardiac autonomic reflex testing (Ewing's battery of tests), orocecal transit time using hydrogen breath analysis |
| Topics | Meditation |
| Keywords | Diabetes mellitus Mindfulness meditation |
| Key findings | The protocol aims to determine whether a 12-week mindfulness meditation program, added to usual care, improves glycaemic control (primarily HbA1c) in patients with type 2 diabetes, and to examine possible mediating mechanisms including stress hormones, insulin resistance, and autonomic function. No results are reported; the trial is registered (SLCTR/2021/015). |
Abstract
Sri Lanka is faced with the challenge of managing a large population with diabetes mellitus by 2030. Psychological stress plays a major role in disease outcome by exerting physiological, psychological and social effects on individuals with chronic disorders. Meditation-based interventions have positive effects on the management of stress and diabetes, which are mediated via modulation of neuro-humoral mechanisms and autonomic functions, among others. Mechanisms of bio-physiological effects of meditation are considered to be through reduction of stress hormones, improvement of insulin resistance and improvement of autonomic dysfunction. This study will be conducted as an open-label, randomized controlled clinical trial in the Faculty of Medicine, University of Colombo. The aim is to investigate the effects of meditation on glycaemic control and possible mechanisms of how meditation affects glycaemic control in patients with type 2 diabetes. The study was approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo (ERC/2019/094). Patients who are attending the professorial unit medical clinic with type 2 diabetes (172 in total) will be recruited based on inclusion-exclusion criteria. Patients who have never meditated or rarely meditated (less than once every three months) will be randomized using block randomization to meditation and waitlisted arms (1:1 allocation ratio). The meditation arm will undergo a mindfulness meditation program (selected after studying several meditation methods) conducted by a qualified instructor weekly for a period of 12 weeks in addition to usual care, while the waitlisted arm will only receive usual care. Daily meditation practices will be recorded in a diary. The primary outcome measure is HbA1c. Secondary outcome measures are fasting blood sugar, fructosamine, insulin resistance (calculated using fasting serum insulin), 24-h urinary cortisol, body mass index, cardiac autonomic reflex testing (Ewing's battery of tests) and orocecal transit time using hydrogen breath analysis. All these will be done prior to commencement of the intervention and after 3 months in both arms. Data will be analysed using SPSS V-23. This study aims to identify the effect of mindfulness meditation on glycaemic control and the possible mechanisms (neuro humoral and autonomic functions) by which beneficial effects are mediated. Registered under Sri Lanka Clinical Trial Registry: SLCTR/2021/015 The Universal Trial Number (UTN) U1111-1266-8640.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 9
- The meeting of meditative disciplines and western psychology: A mutually enriching dialogue. American Psychologist 2006
- Distinct Neural Activity Associated with Focused-Attention Meditation and Loving-Kindness Meditation PLoS One August 15, 2012
- Effect of meditation on autonomic function in healthy individuals: A longitudinal study. Journal of Family Medicine and Primary Care August 25, 2020
- The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus Journal of Diabetes Research June 28, 2018
- Effect of 6 Months of Meditation on Blood Sugar, Glycosylated Hemoglobin, and Insulin Levels in Patients of Coronary Artery Disease. International Journal of Yoga May 1, 2018
and 4 more in the library