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The Effects of Light on Glucose Metabolism

Primary Purpose

Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Exposure to bright light during the day

Exposure to dim light during the day

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Circadian Rhythm

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

bright light during the day

dim light during the day

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postprandial glucose (mg/dL)

Assessed with a continuous glucose monitor (CGM)

Secondary Outcome Measures

Glucose levels (mmol/L) in the postprandial state

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

Free fatty acid levels (µmol/L) in the postprandial state

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

Triglycerides levels (mmol/L) in the postprandial state

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

Insulin levels (µU/mL) in the postprandial state

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

Continuous interstitial glucose (mg/dL)

Assessed with continuous glucose monitor (CGM)

Energy expenditure

continuous measurement with whole room indirect calorimetry

Core body temperature (CBT) and skin temperature

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

Full Information

NCT ID

NCT03829982

First Posted

January 10, 2019

Last Updated

September 23, 2020

Sponsor

Maastricht University

Collaborators

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03829982

Brief Title

The Effects of Light on Glucose Metabolism

Official Title

The Effects of Light on Glucose Metabolism

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 13, 2018 (Actual)

Primary Completion Date

February 7, 2020 (Actual)

Study Completion Date

February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University

Collaborators

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State

Keywords

Circadian Rhythm

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bright light during the day

Arm Type

Experimental

Arm Description

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.

Arm Title

dim light during the day

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exposure to bright light during the day

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exposure to dim light during the day

Intervention Description

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 Outcome Measure Information:

Title

Postprandial glucose (mg/dL)

Description

Assessed with a continuous glucose monitor (CGM)

Time Frame

Study Day 1-3

Secondary Outcome Measure Information:

Title

Glucose levels (mmol/L) in the postprandial state

Description

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

Time Frame

Study Day 2-3

Title

Free fatty acid levels (µmol/L) in the postprandial state

Description

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

Time Frame

Study Day 2-3

Title

Triglycerides levels (mmol/L) in the postprandial state

Description

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

Time Frame

Study Day 2-3

Title

Insulin levels (µU/mL) in the postprandial state

Description

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

Time Frame

Study Day 2-3

Title

Continuous interstitial glucose (mg/dL)

Description

Assessed with continuous glucose monitor (CGM)

Time Frame

Study Day 1-3

Title

Energy expenditure

Description

continuous measurement with whole room indirect calorimetry

Time Frame

Study Day 1-3

Title

Core body temperature (CBT) and skin temperature

Description

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

Time Frame

Study Day 1-3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wouter van Marken Lichtenbelt, Prof. Dr.

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 ER

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35106618

Citation

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.

Results Reference

derived

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The Effects of Light on Glucose Metabolism

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