Status:
COMPLETED
Metabolic Effects of Natural Office Light in Type 2 Diabetes
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Velux Fonden
University of Geneva, Switzerland
Conditions:
Diabetes Mellitus, Type 2
Circadian Dysregulation
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the...
Detailed Description
Obesity and type 2 diabetes (T2D) are both strongly associated with a westernized lifestyle of low physical activity levels and high caloric intake. However, recently it has been recognized that also ...
Eligibility Criteria
Inclusion
- 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)
- T2DM 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
Exclusion
- 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
- Frequent engagement in programmed exercise as judged by the investigator
- Any medication that will interfere with the study outcomes or hamper the safety of the participant
- Alcohol consumption of \>2 servings per day for men and \>1 serving per day for woman
- Significant food allergies/intolerance (seriously hampering study meals)
- 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
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
- Smoking in the past 6 months
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05263232
Start Date
March 16 2022
End Date
April 18 2023
Last Update
August 15 2023
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands