Insomnia treatment and glycemic outcomes in type 2 diabetes
Not Applicable
Completed
- Conditions
- 10040991<p>T2DM and insomnia.</p>
- Registration Number
- NL-OMON23530
- Lead Sponsor
- VU Medical Center
- Brief Summary
Yes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 57
Inclusion Criteria
We recruit people with T2DM and self-reported insomnia.
Exclusion Criteria
We will exclude participants who self-report the following psychiatric problems depression, schizophrenia, psychosis or suicidality; as well as those on medication affecting sleep (i.e. anti-psychotics, anxiolytic), pregnant, working night shifts or reporting excessive alcohol use (>21 alcoholic consumptions per week). People who answer yes to the questions did you receive psychological treatment in the last six months for insomnia will also be excluded. Those suffering from additional sleep disorders will not be excluded, but their diagnosis will be accounted for in the analysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters/endpoints: at baseline, 3 months and 6 months, we will determine glycaemic control, measured by levels of HbA1c.</p><br>
- Secondary Outcome Measures
Name Time Method <p>At baseline, 3 months and 6 months fasting glucose and diabetes medication use as well as sleep, measured by validated questionnaires, sleep diaries, accelerometers and sleep medication prescriptions. Additionally, at baseline, 3 months and 6 months cardiovascular risk factors, including BMI, waist circumference, lipid levels, cholesterol levels, dietary intake, physical activity, mood and quality of life are measured. These parameters are determined using anthropometrical measurements, blood pressure measurements, lipid levels by measuring triglycerides and cholesterol, while dietary intake is measured using a food frequency questionnaire, physical activity by wearing an accelerometers, while mood and quality of life are measured by validated questionnaires.</p><br>