Pillow or Pills? The role of sleep in the glycaemic progression of T2DM

Completed

Conditions: insomnia
10018424
inability to sleep
10040991

Registration Number: NL-OMON48417

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

• Able to speak, write and understand Dutch;
• Voluntary participation;
• >= 18 years of age;
• Access to a computer and the internet;
• Provided written informed consent;
• Willing to comply with the study procedures ;
• Meeting criteria of diagnosis insomnia (DSM-5) as assessed by the online
baseline screening
- Difficulty initiating or maintaining sleep for at least 3 nights per week,
- for at least 3 months,
- causing clinically significant distress or impairment in daily functioning.
Daytime consequences will be assessed using 5 items introduced by Espie et al.
(2012)

Exclusion Criteria

• Working night shifts;
• Meeting criteria of the diagnosis of sleep apnoea;
• Using medication affecting sleep (i.e. anti-psychotics, anxiolytic);
• Having received psychological treatment for insomnia in the last six months;
• Pregnancy or breast feeding during the trial;
• Current depression, schizophrenia, psychosis or suicidal ideation;
• Alcohol consumption > 21 units/week;
• Not willing to give up blood donation during the study;
• Any significant medical reason for exclusion as determined by the
investigator.

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<br /><br>determine glycaemic control, measured by levels of HbA1c.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At baseline, 3 months and 6 months cardiovascular risk factors, including<br /><br>fasting glucose and diabetes medication use as well as sleep, measured by<br /><br>validated questionnaires, sleep dairies, accelerometers and sleep medication<br /><br>prescription. In addition, BMI, waist circumference, lipid levels, cholesterol<br /><br>levels, dietary intake, physical activity, mood and quality of life measured.<br /><br>These parameters are determined using anthropometrical measurements, blood<br /><br>pressure measurements, lipid levels by measuring triglycerides and cholesterol,<br /><br>while dietary intake will be measured using a food frequency questionnaire,<br /><br>physical activity by wearing an accelerometers, while mood and quality of life<br /><br>are measured by validated questionnaires. </p><br>