To investigate whether a reduction in social jetlag for 3 weeks can improve glycemic and metabolic control, sleep, mood and quality of life in people with (pre)diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is , glycemic control, measured as HbA1c after 12 weeks,
comparing the intervention and control group in an intention to treat analysis.
Secondary outcome
1)social jetlag, measured using questionnaires and objective measurements after
4 and 12 weeks 2) Glycemic control measured as fasting glucose, HOMA-IR insulin
resistance and hypoglycemic sensations and diabetes medication; 2h glucose
tolerance 3) metabolic outcomes, including weight, BMI, waist, fat percentage,
blood pressure, ; 4) mood including depression, fatigue and anxiety; 5) quality
of life.
Additionally, we will assess factors that might play a role (possible mediators
and confounders): Dim Light Melatonin Onset (DLMO) in a subgroup, physical
activity, age, sex, ethnicity, education status, stress level, diet, alcohol
consumption, smoking, work status and other medication, nervous system activity
and cardiovascular health, sleep measured as sleep timing, sleep quality, sleep
duration and phases.
Background summary
Social jetlag is a chronic disruption of sleep timing that is characterized by
different sleep timing during workdays and free days. Social jetlag has been
associated with adverse glucose metabolism, insulin sensitivity and parameters
of metabolic syndrome and Type 2 Diabetes (T2D).
Study objective
To investigate whether a reduction in social jetlag for 3 weeks can improve
glycemic and metabolic control, sleep, mood and quality of life in people with
(pre)diabetes.
Study design
A randomized controlled trial.
Intervention
Bright light therapy (5000 lux) emitted by Vitamine-L (Lumie, UK) or dim light
(10 lux) for 30 minutes each morning, following sleep advance instructions, and
wearing bright light dimming goggles every evening for a period of 3weeks. The
control group adheres to their regular sleep habits and conditions.
Study burden and risks
For the baseline visit, people will be asked to come to the research center
twice for a visit of 1 and one of 1,5-2,5 hours subsequently. In between the
visits they will be asked to perform some measurements themselves from home (in
total this takes 2 hours) and to wear an accelerometer and sleep measuring
headband for 7 days. During the second visit, we will draw a small amount of
blood (8ml total (+ 22ml for the combination group)). At the baseline visit, 30
participants will be allocated to the intervention group and will be asked to
follow a minimally invasive study protocol to reduce their social jetlag. The
control group retains their regular sleeping habits. After a 3-week
intervention period, participants receive another accelerometer and sleep
measuring headband to wear for 7 days and are invited back to the research
center for the same visit as the second baseline visit of 1,5 hours
approximately. This is repeated once more after 8 weeks.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
60 people with pre-diabetes and diabetes with >1 hour social jetlag from
earlier cohorts who have provided consent to be informed about future research
will be included.
Exclusion criteria
- Excessive alcohol use (>14 alcoholic consumptions per week);
- Having crossed more than 1 time zone in the month prior to participation;
- Having any other form of diabetes not considered type 2 diabetes (e.g.
steroid-induced diabetes, diabetes type 3c, MODY, LADA).
- Working shifts more than once per month;
- Unable to provide written informed consent
- Visually impaired
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ISRTCN nog niet bekend |
| CCMO | NL85663.018.23 |