Evidence map›Paper›PMID 38834315›Full record

ArticleBMJ open2024

Targeting self-care adherence for glycaemic control in multimorbid type 2 diabetes mellitus with depression using bupropion: a protocol for cross-over randomised controlled trial.

Muhammad Aaqib Shamim, Ravindra Shukla, Mukesh Kumar Swami, Shival Srivastav, Anindita Pradhan, Suraj Singh Yadav, Abhishek Anil, Aswini Saravanan, Shoban Babu Varthya, Surjit Singh and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

11 authors.

Muhammad Aaqib Shamim *Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India dr.prad99@gmail.com aaqibsh@gmail.com.ORCID 0000-0003-3418-8171
Ravindra ShuklaDepartment of Endocrinology & Metabolism, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Mukesh Kumar SwamiDepartment of Psychiatry, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Shival SrivastavDepartment of Physiology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Anindita PradhanDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Suraj Singh YadavCentre of Excellence for Tribal Health, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Abhishek AnilDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Aswini SaravananDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.ORCID 0000-0001-6680-0762
Shoban Babu VarthyaDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.ORCID 0000-0002-7163-0400
Surjit SinghDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.ORCID 0000-0002-8990-3235
Pradeep Dwivedi *Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India dr.prad99@gmail.com aaqibsh@gmail.com.ORCID 0000-0001-6709-3780

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDiabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases. RESEARCH DESIGN AND

methodsThis cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events. ETHICS AND DISSEMINATION: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media. TRIAL REGISTRATION NUMBER: CTRI/2022/10/046411.

Indexed as

BupropionCross-Over StudiesDepressionDiabetes Mellitus, Type 2Self CareAntidepressive Agents, Second-GenerationGlycemic ControlHumansMaleMedication AdherenceMultimorbidityQuality of LifeRandomized Controlled Trials as TopicAntidepressive Agents, Second-GenerationBupropionCLINICAL PHARMACOLOGYDepression & mood disordersDIABETES & ENDOCRINOLOGYmultimorbiditySelf Care

Identifiers

PMID38834315
PMCPMC11163640

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Registered trials

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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.