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Completed

NCT Number: NCT03829982

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exposure to bright light during the day

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Postprandial glucose (mg/dL)

    Time frame: Study Day 1-3

    Assessed with a continuous glucose monitor (CGM)

Secondary outcomes

  1. Glucose levels (mmol/L) in the postprandial state

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Study Day 2-3

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

  5. Continuous interstitial glucose (mg/dL)

    Time frame: Study Day 1-3

    Assessed with continuous glucose monitor (CGM)

  6. Energy expenditure

    Time frame: Study Day 1-3

    continuous measurement with whole room indirect calorimetry

  7. Core body temperature (CBT) and skin temperature

    Time frame: Study Day 1-3

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

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

  • Maastricht University Medical Center

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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