Light Therapy for better Mood and Metabolic control: a randomised double-blind placebo-controlled clinical trial in patients with Type 2 Diabetes Mellitus and Depression

Light Therapy for better Mood and Metabolic control: a randomised double-blind placebo-controlled clinical trial in patients with Type 2 Diabetes Mellitus and Depression - Light therapy for Depression and Diabetes (LiDDia)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44883

Enrollment

Registered

2014-03-31

Start date

2014-04-24

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult onset diabetes Depression

Interventions

Partcipants will be randomly assigned to the experimental or control condition: 4 week exposure to bright white-yellowish light, 10.000Lux, 0.5 hour every morning, or 4 week exposure to dim green li

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (pilot studie): (1) Age 18-75 years (2) Physically and psychiatrically healthy, as judged by an expert panel;Patients: (1) Age 18 years or older (2) Type 2 Diabetes Mellitus, as judged by an expert panel (3) Depression (DSM-IV)

Exclusion criteria

Exclusion criteria: Healthy subjects (pilot studie): (1) A recent history of a serious medical event, as judged by an expert panel (2) Hypersensitivity to drugs used (3) Pregnancy (4) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study (5) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family;Patients: (1) Recent history (

Design outcomes

Secondary

Measure	Time frame
Depression o Mean change in depressive symptoms (IDS-SR) in the active versus placebo condition (T0-T8). o Depression (sustained) remission rates in the active versus placebo condition (remission is a priori defined as a score of 13 or less (IDS-SR) at T4; sustained remission is a priori defined as a score of 13 or less (IDS-SR) at T4 and T8). o Temporal changes in depressive symptoms (IDS-SR) in the active versus placebo condition (T0,T1, T2, T3, T4, T8). Diabetes o Mean change HEC-derived M-value, as measure of whole-body insulin sensitivity in the active versus placebo condition (T0-T4). o Mean change in HbA1c in the active versus placebo condition (T0-T4, T0-T8). o Mean change in fasting plasma glucose in the active versus placebo condition (T0-T4, T0-T8). o Mean change in self-reported glucose measures and insulin dosages (if applicable) in the active versus placebo condition (T0-T4, T0-T8). Anxiety, emotional functioning in diabetes, quality of life, and disability o Mean change in anxiety symptoms in the active versus placebo condition (T0-T4, T0-T8). o Temporal changes in anxiety symptoms in the active versus placebo condition (T0-T4, T0-T8). o Mean change in emotional functioning in diabetes in the active versus placebo condition (T0-T4, T0-T8). o Mean change in quality of life in the active versus placebo condition (T0-T4, T0-T8). o Mean change in disability in the active versus placebo condition (T0-T4, T0-T8) Primary mediators o Mean change in diurnal cortisol variability in the active versus placebo condition (T0-T4, T0-T8). o Mean change in objective actigraphic measures of sleep duration and circadian rhythmicity in the active versus placebo condition (T0-T4, T0-T8). o Mean change in subjective measures of sleep duration and quality and circadian rhythmicity in the active versus placebo condition (T0-T4, T0-T8). Secondary mediators o Mean change in the ANS-balance in the active versus placebo condition (subgroup) (	—

Measure

Time frame

Depression o Mean change in depressive symptoms (IDS-SR) in the active versus placebo condition (T0-T8). o Depression (sustained) remission rates in the active versus placebo condition (remission is a priori defined as a score of 13 or less (IDS-SR) at T4; sustained remission is a priori defined as a score of 13 or less (IDS-SR) at T4 and T8). o Temporal changes in depressive symptoms (IDS-SR) in the active versus placebo condition (T0,T1, T2, T3, T4, T8). Diabetes o Mean change HEC-derived M-value, as measure of whole-body insulin sensitivity in the active versus placebo condition (T0-T4). o Mean change in HbA1c in the active versus placebo condition (T0-T4, T0-T8). o Mean change in fasting plasma glucose in the active versus placebo condition (T0-T4, T0-T8). o Mean change in self-reported glucose measures and insulin dosages (if applicable) in the active versus placebo condition (T0-T4, T0-T8). Anxiety, emotional functioning in diabetes, quality of life, and disability o Mean change in anxiety symptoms in the active versus placebo condition (T0-T4, T0-T8). o Temporal changes in anxiety symptoms in the active versus placebo condition (T0-T4, T0-T8). o Mean change in emotional functioning in diabetes in the active versus placebo condition (T0-T4, T0-T8). o Mean change in quality of life in the active versus placebo condition (T0-T4, T0-T8). o Mean change in disability in the active versus placebo condition (T0-T4, T0-T8) Primary mediators o Mean change in diurnal cortisol variability in the active versus placebo condition (T0-T4, T0-T8). o Mean change in objective actigraphic measures of sleep duration and circadian rhythmicity in the active versus placebo condition (T0-T4, T0-T8). o Mean change in subjective measures of sleep duration and quality and circadian rhythmicity in the active versus placebo condition (T0-T4, T0-T8). Secondary mediators o Mean change in the ANS-balance in the active versus placebo condition (subgroup) (

—

Primary

Measure	Time frame
o Mean change in IDS-SR scores in the active versus placebo condition (T0-T4).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)