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 |
Trial Parameters
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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, zol
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