Evidence map›Paper›PMID 36176007›Full record

ArticleTrials2022

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

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. [Lifetide biofeedback intervention in type 2 diabetic patients: a pilot observation].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2023
    Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

K P C DalpataduFaculty of Medicine, University of Colombo, No:25, Kinsey Road, Colombo, 8, Sri Lanka. chamila@physiol.cmb.ac.lk.ORCID http://orcid.org/0000-0001-6564-2387
P GalappatthyFaculty of Medicine, University of Colombo, No:25, Kinsey Road, Colombo, 8, Sri Lanka.
P KatulandaFaculty of Medicine, University of Colombo, No:25, Kinsey Road, Colombo, 8, Sri Lanka.
S JayasingheFaculty of Medicine, University of Colombo, No:25, Kinsey Road, Colombo, 8, Sri Lanka.
University of Colombo · LK

Funding

World Bank Group Accelerating Higher Education Expansion Development Grant No. 6026-LK/8743-LK (AHEAD grant-81)
6 · The paper itself

Abstract

backgroundSri 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.

methodsThis 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. DISCUSSION: 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.

trial registrationRegistered under Sri Lanka Clinical Trial Registry: SLCTR/2021/015 The Universal Trial Number (UTN) U1111-1266-8640.

Indexed as

Diabetes Mellitus, Type 2Insulin ResistanceInsulinsMeditationBlood GlucoseFructosamineGlycated HemoglobinHumansHydrocortisoneHydrogenRandomized Controlled Trials as TopicTreatment OutcomeBlood GlucoseFructosamineGlycated HemoglobinHydrocortisoneHydrogenInsulinsDiabetes mellitusMechanisms of metabolic controlMindfulness meditation

Identifiers

PMID36176007
PMCPMC9523920
OpenAlexW4297963106

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.