The Effects of Light on Glucose Metabolism

This study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Intervention / Treatment: Behavioral: Exposure to bright light during the day; Behavioral: Exposure to dim light during the day

Detailed Description

Light has a major influence on the biological clock and several studies suggest that bright light during the day and dim light in the evening are beneficial for the circadian timing system. Nowadays, large parts of the population spend 90% of their time indoors and are thereby exposed to artificial lighting instead of daylight. The artificial light levels are relatively low during the day and continue relatively late in the evening. The lack of a clear natural light-dark cycle could results in delayed timing of the biological clock relative to the behaviour. Optimizing the lighting conditions under controlled laboratory settings might lead to better alignment of the biological clock, which in turn could improve metabolic parameters such as glucose control.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 ER
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Caucasian
• BMI 25-35 kg/m2
• Stable weight (+/- 3 kg in the last 3 months)

• One of the four criteria for prediabetes:

  • Impaired fasting glucose (6.1 mM to 6.9 mM)
  • Blood glucose values 7.8 - 11.1 mM 2h after glucose drink consumption during the oral glucose tolerance test (OGTT) in screening
  • Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as determined using the oral glucose insulin sensitivity (OGIS120) index
  • HbA1c of 5.7 - 6.4%.

Exclusion Criteria:

• Fasting plasma glucose ≥7.0 mM
• Blood donation one month prior to study and three months after finishing study.
• Participants with extreme chronotypes (going to bed extremely late/early).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bright light during the day; Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.	Behavioral: Exposure to bright light during the day; Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.
Experimental: dim light during the day; Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.	Behavioral: Exposure to dim light during the day; Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose (mg/dL)	Assessed with a continuous glucose monitor (CGM)	Study Day 1-3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels (mmol/L) in the postprandial state	venous blood draw every 30 min for 4 hours after breakfast and after dinner	Study Day 2-3
Free fatty acid levels (µmol/L) in the postprandial state	venous blood draw every 30 min for 4 hours after breakfast and after dinner	Study Day 2-3
Triglycerides levels (mmol/L) in the postprandial state	venous blood draw every 30 min for 4 hours after breakfast and after dinner	Study Day 2-3
Insulin levels (µU/mL) in the postprandial state	venous blood draw every 30 min for 4 hours after breakfast and after dinner	Study Day 2-3
Continuous interstitial glucose (mg/dL)	Assessed with continuous glucose monitor (CGM)	Study Day 1-3
Energy expenditure	continuous measurement with whole room indirect calorimetry	Study Day 1-3
Core body temperature (CBT) and skin temperature	Measured with a telemetric pill (CBT) and 14 temperature sensors (iButtons) in degrees celsius	Study Day 1-3

Collaborators and Investigators

• Sponsor: Maastricht University
• Collaborators: Maastricht University Medical Center
• Investigators: Principal Investigator: Wouter van Marken Lichtenbelt, Prof. Dr., Maastricht University

Publications and helpful links

General Publications

• Harmsen JF, Wefers J, Doligkeit D, Schlangen L, Dautzenberg B, Rense P, van Moorsel D, Hoeks J, Moonen-Kornips E, Gordijn MCM, van Marken Lichtenbelt WD, Schrauwen P. The influence of bright and dim light on substrate metabolism, energy expenditure and thermoregulation in insulin-resistant individuals depends on time of day. Diabetologia. 2022 Apr;65(4):721-732. doi: 10.1007/s00125-021-05643-9. Epub 2022 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Circadian Rhythm
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: NL63655.068.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No