Metabolic Effects of Natural Office Light in Type 2 Diabetes

NCT05263232 | Completed DMC

• 1 other identifier: NL77984.068.21
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.

Conditions

Diabetes Mellitus, Type 2; Circadian Dysregulation

Keywords

circadian rhythm

Outcome Measures

Primary Outcomes (1)

• average 24h blood glucose levels

  Interstistial glucose levels determined by continuous glucose monitoring

  continously over 4.5 days

Secondary Outcomes (9)

• Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure)

  measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5

• Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation)

  measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5

• Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation)

  measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5

• Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose)

  measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5

• Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin)

  measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5

Other Outcomes (12)

• 24 hour energy expenditure

  measured at 8:00, 13:00, 18:00 and 22:30 on Day 4

• 24h whole-body energy metabolism (cabrohydrate oxidation)

  measured at 8:00, 13:00, 18:00 and 22:30 on Day 4

• 24h whole-body energy metabolism (fatty acid oxidation)

  measured at 8:00, 13:00, 18:00 and 22:30 on Day 4

Study Arms (2)

Natural office light

EXPERIMENTAL

Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with wide transparent windows under natural daylight.

Other: Natural or artificial office light exposure

Artificial office light

EXPERIMENTAL

Over 4.5 days, participants will stay inside in an office room from 8:00 to 17:00h with shielded windows under artificial light.

Other: Natural or artificial office light exposure

Interventions

Natural or artificial office light exposure OTHER

Over 4.5 days, participants will stay at our research facilities under different light conditions. Over these days different measurements will take place, including 24h continuous glucose monitoring, 24h blood and saliva sampling, 24h blood pressure and heart rate assessments, 24h core and skin temperature assessments, 24h energy expenditure and whole-body substrate metabolism, and a skeletal muscle biopsy and a mixed meal tolerance test with indirect calorimetry will be performed on the respectively last test day.

Artificial office light; Natural office light

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead
• Velux Fonden: collaborator
• University of Geneva, Switzerland: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: March 2, 2022
• Study Start: March 16, 2022
• Primary Completion: November 30, 2022
• Study Completion: April 18, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

NL (1)