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Natural daylight to improve 24h metabolism and glucose control in type 2 diabetes individuals

Natural daylight to improve 24h metabolism and glucose control in type 2 diabetes individuals - Natural office light and diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51072
Enrollment
18
Registered
2021-12-03
Start date
2022-03-16
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

adult-onset diabetes type 2 diabetes

Interventions

Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during daytime over 4.5 days. For both conditions, the evening and night will be spent u

Sponsors

University of Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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 =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.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is average 24h blood glucose assessed with a continuous glucose monitor.

Secondary

MeasureTime frame
Secondary study endpoints refer to postprandial metabolism upon a mixed-meal tolerance test and circadian transcriptome, lipidome and myokine secretion analyses in skeletal muscle tissue with culturing of human primary myotubes to assess circadian reporter characteristics. Other exploratory parameters include: • 24h blood profiles: o metabolic compounds (glucose, triglycerides, free fatty acids) o hormones (insulin) o mass spectrometry-based lipidomics • Sleep quality questionnaires: LSEQ and PSQI • 24h indirect calorimetry: substrate metabolism and energy expenditure • Actigraphy measures: activity count, sleeping times • 24h blood pressure and heart rate (ambulatory) • 24h saliva profiles: o Melatonin and cortisol • Core body temperature and skin temperatures • mRNA and protein levels in blood PBMC*s of markers involved in the molecular clock • Body composition (BodPod)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)