Evidence map›Paper›PMID 38997765›Full record

ArticleTrials2024

A randomized controlled trial to assess if changing sleep timing can improve glucose metabolism in people with prediabetes and type 2 diabetes.

Emma J Bouman, Romy Slebe, Dirk Jan Stenvers, Petra J M Elders, Joline W J Beulens, Femke Rutters

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Emma J BoumanAmsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Meibergdreef 9, Amsterdam, The Netherlands. e.bouman1@amsterdamumc.nl.ORCID http://orcid.org/0000-0001-6559-8961
Romy SlebeAmsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Meibergdreef 9, Amsterdam, The Netherlands.
Dirk Jan StenversAmsterdam UMC location University of Amsterdam, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, The Netherlands.
Petra J M EldersAmsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands.
Joline W J BeulensAmsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Meibergdreef 9, Amsterdam, The Netherlands.
Femke RuttersAmsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Meibergdreef 9, Amsterdam, The Netherlands.

Funding

Diabetes Fonds 2019.82.002
6 · The paper itself

Abstract

backgroundSocial jetlag is a chronic disruption of sleep timing that is characterized by different sleep timing during workdays and free days. Social jetlag has been associated with disturbed glucose metabolism, insulin resistance, and increased risk of metabolic syndrome and type 2 diabetes. In this study, we aim to investigate whether a combination of bright light therapy in the morning, bright light reduction in the evening and sleep advance instructions for 3 weeks reduces social jetlag and if this results in improvement of glycemic and metabolic control, sleep, mood and quality of life after 3 and 12 weeks in people with prediabetes and type 2 diabetes and to assess possible mediators, compared to regular sleep habits.

methodsIn this randomized controlled trial, 60 people with prediabetes or type 2 diabetes with > 1 h social jetlag will be recruited. The intervention consists of bright light therapy (5000 lx) emitted by Vitamine-L (Lumie, UK) for 30 min each morning, combined with the advice to follow sleep advance instructions and to wear bright light-dimming goggles every evening for a period of 3 weeks. The control group adheres to their regular sleep habits and conditions. The primary outcome is glycated hemoglobin (HbA1c) after 12 weeks comparing the intervention and control in an intention-to-treat analysis. Secondary outcomes at 3 and 12 weeks are (1) social jetlag; (2) insulin sensitivity, fasting blood glucose, glucose-lowering medication use, and frequency of perceived hypoglycemia; (3) metabolic outcomes, including body mass index (BMI), waist circumference, body fat percentage, and blood pressure; (4) mood, including depression, fatigue and anxiety (measured with questionnaires); and (5) quality of life measured using EQ5D questionnaire. To assess other factors that might play a role as possible mediators, we will measure (para)sympathetic nervous system activity assessed with ECGs and electrochemical skin conductance tests, sleep quality and sleep phase distribution assessed with a sleep measuring headband (ZMax), the Dim Light Melatonin Onset in saliva samples (in a subgroup) at 3 and 12 weeks, the feeling of satiety and satiation with a 10-cm visual analog scale (VAS), diet using a food frequency questionnaire, and physical activity using an accelerometer (ActiGraph). DISCUSSION: Social jetlag can contribute to poorer glycemic control and metabolic control in those with type 2 diabetes. With this intervention, we aim to reduce social jetlag and thereby improve glycemic and metabolic control. This could offer a way to improve overall population health and to reduce the disease burden of type 2 diabetes.

trial registrationISRCTN registry ISRCTN11967109 . Registered on 9 May 2024.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Glycated HemoglobinPrediabetic StateQuality of LifeSleepAdultAffectCircadian RhythmFemaleHumansJet Lag SyndromeMaleMiddle AgedRandomized Controlled Trials as TopicTime FactorsBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanCircadian rhythmGlycemic controlMetabolic controlRandomized controlled trialSocial jetlagType 2 diabetes mellitus

Identifiers

PMID38997765
PMCPMC11241910

What Socratic holds

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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 Socratic graph.