atural daylight to improve 24h metabolism and glucose control in type 2 diabetes individuals
- Conditions
- adult-onset diabetestype 2 diabetes10018424
- Registration Number
- NL-OMON51072
- Lead Sponsor
- niversity of Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
• Participants are able to provide signed and dates written consent prior to
any study specific procedures
• Male + females (postmenopausal defined as at least 1 year post cessation of
menses)
• T2D duration at least 1 year
• BMI: >= 25 kg/m²
• Age: 40-75
• Well-controlled diabetes with respect to glycemic control and on stable
anti-diabetes medication regimes
• Habitual bedtime of 23:00 ± 2h
• Regular sleep duration (7-9 h/night)
• Stable dietary habits: no weight gain or loss > 5 kg in the last three months
• Insulin treatment
• Uncontrolled hypertension
• Signs of active diabetes-related co-morbidities like active cardiovascular
diseases, active diabetic foot, polyneuropathy or retinopathy
• Signs of active liver or kidney malfunction
• Use of SGLT2 inhibitors
• Using > 400mg caffeine daily (more than 4 coffee or energy drink)
• Extreme early bird or extreme night person (score <=30 or >=70 on MEQ-SA
questionnaire)
• shift work or travel across more than one time zone in the 3 months before
the study
• Heavily varying sleep-wake rhythm
• engagement in programmed exercise for more than 3h/week
• Any medication that will interfere with the study outcomes or hamper the
safety of the participant
• Alcohol consumption of >2 servings per day for man and >1 serving per day for
woman
• Subjects who do not want to be informed about unexpected medical findings
during the screening /study, or do not wish that their physician is informed, 1
month prior to the screening visit
• Significant food allergies/intolerance (seriously hampering study meals)
• Participation in another biomedical study within 1 month before the first
study visit
• Smoking in the past 6 months
A medical doctor will judge participation eligibility based on the medical
history questionnaire, medication use and fasting blood parameters. If the
medical doctor advises that a patient cannot participate, the patient will be
excluded from enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is average 24h blood glucose assessed with a continuous<br /><br>glucose monitor.</p><br>
- Secondary Outcome Measures
Name Time Method