NCT03829982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

January 10, 2019

Last Update Submit

September 23, 2020

Conditions

Diabetes Mellitus, Type 2Glucose IntolerancePrediabetic State

Keywords

Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose (mg/dL)

    Assessed with a continuous glucose monitor (CGM)

    Study Day 1-3

Secondary Outcomes (7)

  • Glucose levels (mmol/L) in the postprandial state

    Study Day 2-3

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

    Study Day 2-3

  • Triglycerides levels (mmol/L) in the postprandial state

    Study Day 2-3

  • Insulin levels (µU/mL) in the postprandial state

    Study Day 2-3

  • Continuous interstitial glucose (mg/dL)

    Study Day 1-3

  • +2 more secondary outcomes

Study Arms (2)

bright light during the day

EXPERIMENTAL

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

dim light during the day

EXPERIMENTAL

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

Interventions

Exposure to bright light during the dayBEHAVIORAL

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.

bright light during the day
Exposure to dim light during the dayBEHAVIORAL

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.

dim light during the day

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 35106618DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntolerancePrediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Wouter van Marken Lichtenbelt, Prof. Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

February 4, 2019

Study Start

July 13, 2018

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

NL(1)