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A randomized control trial to assess if changing sleep timing can improve glucose metabolism in people with (pre)diabetes

A randomized control trial to assess if changing sleep timing can improve glucose metabolism in people with (pre)diabetes - Social jetlag trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56641
Enrollment
60
Registered
2023-11-24
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Bright light therapy (5000 lux) emitted by Vitamine-L (Lumie, UK) or dim light (10 lux) for 30 minutes each morning, following sleep advance instructions, and wearing bright light dimming goggles ev

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 60 people with pre-diabetes and diabetes with >1 hour social jetlag from earlier cohorts who have provided consent to be informed about future research will be included.

Exclusion criteria

Exclusion criteria: - Excessive alcohol use (>14 alcoholic consumptions per week); - Having crossed more than 1 time zone in the month prior to participation; - Having any other form of diabetes not considered type 2 diabetes (e.g. steroid-induced diabetes, diabetes type 3c, MODY, LADA). - Working shifts more than once per month; - Unable to provide written informed consent - Visually impaired

Design outcomes

Primary

MeasureTime frame
The primary outcome is , glycemic control, measured as HbA1c after 12 weeks, comparing the intervention and control group in an intention to treat analysis.

Secondary

MeasureTime frame
1)social jetlag, measured using questionnaires and objective measurements after 4 and 12 weeks 2) Glycemic control measured as fasting glucose, HOMA-IR insulin resistance and hypoglycemic sensations and diabetes medication; 2h glucose tolerance 3) metabolic outcomes, including weight, BMI, waist, fat percentage, blood pressure, ; 4) mood including depression, fatigue and anxiety; 5) quality of life. Additionally, we will assess factors that might play a role (possible mediators and confounders): Dim Light Melatonin Onset (DLMO) in a subgroup, physical activity, age, sex, ethnicity, education status, stress level, diet, alcohol consumption, smoking, work status and other medication, nervous system activity and cardiovascular health, sleep measured as sleep timing, sleep quality, sleep duration and phases.

Countries

Netherlands

Contacts

Public ContactF Rutters

Amsterdam UMC

f.rutters@amsterdamumc.nl+31 20 44 45860

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026