Changing sleep timing to improve glucose metabolism

Not Applicable

• Conditions: Prevention of diabetes for people with social jetlag; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11967109
• Lead Sponsor: Amsterdam UMC Location VUmc

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38997765/ (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 29 July 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Social jetlag (>1h) (calculated as difference between midpoint of sleep during week days and free weekend days)
2. (Pre) diabetes: HbA1c >39 mmol/mol (5.7%), fasting plasma glucose >5.6 mmol/l, or 2-hour OGTT >7.8mmol/l (according to the American Diabetes Association) including the use of any glucose-lowering medication
3. Informed consent to be contacted for future research
4. Willing to comply with the study procedures

Exclusion Criteria

1. Excessive alcohol use (>21 alcoholic consumptions per week);
2. Having crossed more than 1 time zone in the month prior to participation;
3. Working shifts more than once per month;
4. Unable to provide written informed consent;
5. Visually impaired;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control measured as HbA1c levels comparing the intervention and control group in an<br>intention to treat analysis at baseline after 12 weeks.<br>

Secondary Outcome Measures

Name	Time	Method
All outcomes will be measured over the duration of 3 weeks and 12 weeks:<br>1. Other glycemic measures: fasting blood glucose and insulin levels, medication use and frequency of hypoglycemic sensation;<br>2. Metabolic outcomes, including BMI, waist, blood pressure, fat percentage, (para)sympathetic nervous system activity from ECGs and electrochemical skin conductance tests,<br>3. Sleep measured as sleep times, sleep quality and sleep phases using a sleep measuring Headband (only after 3 weeks);<br>4. Mood including depression, fatigue and anxiety measured using questionnaires<br>5. Quality of life measured using the EQ5D questionnaire.<br>6. Additionally, to assess other factors that might play a role (possible mediators), we will assess the Dim Light Melatonin Onset (DLMO) in saliva samples (in a subgroup), feeling of satiety and satiation is assessed using a 10-cm VAS scale and physical activity using an accelerometer.