The Effects of Light on Glucose Metabolism

• Sponsor: Maastricht University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03829982
• Collaborator: Maastricht University Medical Center (Other)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Glucose Intolerance; Prediabetic State	Behavioral: Exposure to bright light during the day; Behavioral: Exposure to dim light during the day	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover AssignmentCrossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Effects of Light on Glucose Metabolism
• Actual Study Start Date: Jul 13, 2018
• Actual Primary Completion Date: Feb 7, 2020
• Actual Study Completion Date: Feb 7, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Postprandial glucose (mg/dL) [Study Day 1-3]

   Assessed with a continuous glucose monitor (CGM)

Secondary Outcome Measures

1. Glucose levels (mmol/L) in the postprandial state [Study Day 2-3]

   venous blood draw every 30 min for 4 hours after breakfast and after dinner

2. Free fatty acid levels (µmol/L) in the postprandial state [Study Day 2-3]

   venous blood draw every 30 min for 4 hours after breakfast and after dinner

3. Triglycerides levels (mmol/L) in the postprandial state [Study Day 2-3]

   venous blood draw every 30 min for 4 hours after breakfast and after dinner

4. Insulin levels (µU/mL) in the postprandial state [Study Day 2-3]

   venous blood draw every 30 min for 4 hours after breakfast and after dinner

5. Continuous interstitial glucose (mg/dL) [Study Day 1-3]

   Assessed with continuous glucose monitor (CGM)

6. Energy expenditure [Study Day 1-3]

   continuous measurement with whole room indirect calorimetry

7. Core body temperature (CBT) and skin temperature [Study Day 1-3]

   Measured with a telemetric pill (CBT) and 14 temperature sensors (iButtons) in degrees celsius

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht	Limburg	Netherlands	6229 ER

Sponsors and Collaborators

• Maastricht University
• Maastricht University Medical Center

Investigators

• Principal Investigator: Wouter van Marken Lichtenbelt, Prof. Dr., Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University
• ClinicalTrials.gov Identifier: NCT03829982
• Other Study ID Numbers: NL63655.068.17
• First Posted: Feb 4, 2019
• Last Update Posted: Sep 24, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maastricht University: Circadian Rhythm
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance; Prediabetic State

Study Results

No Results Posted as of Sep 24, 2020