The Effects of Light on Glucose Metabolism

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effects of Light on Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829982
• Other study ID #: NL63655.068.17
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: February 7, 2020

Study information

• Verified date: September 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose (mg/dL)	Assessed with a continuous glucose monitor (CGM)	Study Day 1-3
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Continuous interstitial glucose (mg/dL)	Assessed with continuous glucose monitor (CGM)	Study Day 1-3
Secondary	Energy expenditure	continuous measurement with whole room indirect calorimetry	Study Day 1-3
Secondary	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