NCT02973412 Chronotype of Patients With Diabetes and Effect on Glycaemic Control
| NCT ID | NCT02973412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,447 participants |
| Start Date | 2016-12-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,447 participants in total. It began in 2016-12-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to explore the associations between chronotype and glycaemic control, cardiometabolic health and other lifestyle factors.
Eligibility Criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. T1DM or established T2DM (\>6months since diagnosis) 3. Male or Female 4. Aged 18-75 years inclusive 5. BMI less than or equal to 45kg/m² inclusive 6. No known sleep disorders except Obstructive Sleep Apnoea (OSA) 7. On any glucose-lowering therapy (T1DM or T2DM) or lifestyle modification for management of T2DM 8. Good command of the English language Exclusion Criteria: 1. Participant is unwilling or unable to give informed consent 2. Anyone without a good command of the English language 3. Anyone \<18 years of age and \>75 years of age 4. BMI greater than 45 kg/m² 5. A regular cannabis user i.e. weekly use 6. Have a terminal illness 7. A known sleep disorder that is not OSA 8. Regular use of the following medicines i.e. Weekly use: (Wakefulness promoting agents Modafinil, Amphetamine derivatives, Methylphenidate; Sedatives including benzodiazepines, Z-drugs (zopiclone, zolpidem \& zaleplon); Melatonin, including Circadin and melatonin analogues; Clonazepam and other drugs for nocturnal movement disorders).
Contact & Investigator
Andrew Hall
PRINCIPAL INVESTIGATOR
Sleep Consultant
Frequently Asked Questions
Who can join the NCT02973412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02973412 currently recruiting?
Yes, NCT02973412 is actively recruiting participants. Contact the research team at sahar.khodabakhsh@uhl-tr.nhs.uk for enrollment information.
Where is the NCT02973412 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT02973412 clinical trial?
NCT02973412 is sponsored by University of Leicester. The principal investigator is Andrew Hall at Sleep Consultant. The trial plans to enroll 3,447 participants.
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