Clinical trial NCT06471634: A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Official title: An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insomnia
Sedentary Behavior
Keywords: Sleep
Insomnia
Sedentary behaviour
Diabetes Mellitus, Type 2
Cognitive Behaviour Therapy insomnia (CBTi)
Behaviour change
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2024-06-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Diabetes Mellitus type 2 for longer than 3 months
* Participant is willing and able to give informed consent to take part in the study.
* Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
* Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.
* Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
* Male or Females.
* ≥ 18 ≤ 75 years of age.
* Able to walk without the use of an assistive device or requiring assistance from another person.
* Not undertaking more than 75 minutes a week of strenuous exercise or sport.
* Not taking opioids
* Be treatment stable for at least 3 months
* Accelerometer measurement of SE ≤ 85%
* An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.

Exclusion Criteria:

* Individuals living with narcolepsy or diagnosed parasomnia
* Individuals with type 1 diabetes or gestational diabetes
* Recent cardiovascular event (within the last 6 months).
* Currently on opioids
* Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
* Individuals living with epilepsy or seizures.
* Shift workers
* Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
* Terminal illness.

Primary outcomes:
measure: Sleep Efficiency (SE) measured using accelerometer data.
timeFrame: Before and after the 12 week intervention/intervention period
Secondary outcomes:
measure: Objectively measured sleep - sleep onset latency
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured sleep - wake after sleep onset
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured sleep - total sleep time
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured sleep - sleep duration variability
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured sleep - sleep midpoint variability
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured sedentary behaviour
timeFrame: Before and after the 12 week intervention/intervention period
measure: Objectively measured physical activity
timeFrame: Before and after the 12 week intervention/intervention period
measure: Subjectively measured sleep - insomnia
timeFrame: Before and after the 12 week intervention/intervention period
measure: Subjectively measured sleep quality -
timeFrame: Before and after the 12 week intervention/intervention period
measure: Subjectively measured sleepiness
timeFrame: Before and after the 12 week intervention/intervention period
measure: Measurement of fatigue
timeFrame: Before and after the 12 week intervention/intervention period
measure: Blood pressure
timeFrame: Before and after the 12 week intervention/intervention period
measure: Fasting blood glucose
timeFrame: Before and after the 12 week intervention/intervention period
measure: Continuous blood glucose
timeFrame: Before and after the 12 week intervention/intervention period
measure: Insulin
timeFrame: Before and after the 12 week intervention/intervention period
measure: Triglycerides
timeFrame: Before and after the 12 week intervention/intervention period
measure: Cholesterol
timeFrame: Before and after the 12 week intervention/intervention period
measure: Physical function - the short physical performance battery
timeFrame: Before and after the 12 week intervention/intervention period
measure: Physical function - the sit to stand-60
timeFrame: Before and after the 12 week intervention/intervention period
measure: Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)
timeFrame: Before and after the 12 week intervention/intervention period
measure: Cognitive function - verbal fluency test
timeFrame: Before and after the 12 week intervention/intervention period
measure: Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)
timeFrame: Before and after the 12 week intervention/intervention period
measure: Weight
timeFrame: Before and after the 12 week intervention/intervention period
measure: Height
timeFrame: Before and after the 12 week intervention/intervention period
measure: Body mass index (BMI)
timeFrame: Before and after the 12 week intervention/intervention period
measure: Body composition - via bioimpedance
timeFrame: Before and after the 12 week intervention/intervention period
measure: Depression - The Patient Health Questionnaire-9 (PHQ9)
timeFrame: Before and after the 12 week intervention/intervention period
measure: Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)
timeFrame: Before and after the 12 week intervention/intervention period
measure: Food intake - food diaries
timeFrame: Before and after the 12 week intervention/intervention period
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Diabetes Research Centre University Hospitals Leicester
state: Leicestershire
Study officials:
affiliation: Leicester Diabetes Centre
name: Melanie Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References: