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Table 3 Clinical and device-based measures collected in the in-person visit clinical assessments

From: Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: ‘OPTIMISE your health’ trial protocol

Component

Key constructs

Measures

Primary / secondary outcomes

Other measures

Fasting blood draws

Glycaemic control

Glycosylated haemoglobin (HbA1c %, HbA1c mmol/mol)*

 

Fasting glucose metabolism

Glucose and Insulin

 

Fasting lipid metabolism

LDL, HDL, Total cholesterol, Triglycerides

 

Inflammatory markers

Hs-CRP, TNF-α, IL-6, IL-1B, Adiponectin, Leptin

IFNy, IL-10, IL-12, IL-8, IL-4

Neurotrophic factors

BDNF, IGF-1

NGF, VEGF-A

Genetic risk factors

 

ApoE4

2 h Oral Glucose Tolerance Test

Postprandial metabolism of glucose & insulin

iAUC glucose, iAUC insulin, 2 h post-prandial glucose, 2 h post-prandial insulin

 

Anthropometric

Body weight & body composition

Weight, waist circumference, DXA assessed total and regional fat mass, lean mass, total body fat percentage, DXA software estimated visceral adipose tissue mass

Height, BMI

Vascular

Blood pressure & heart rate

Resting systolic blood pressure, diastolic blood pressure, mean arterial pressure

Resting heart rate

Flow Mediated Dilation

Post-deflation peak vessel diameter compared to resting diameter (FMD%)

Shear rate (cm/s), Shear rate AUC

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Visual learning and new memory

Paired Associates Learning total errors (adjusted)b (PAL TEA), PAL total errors 12 shapes (adjusted)

PAL total errors, PAL total errors 12 patterns

Reaction Time

Reaction Time (RTI) simple median reaction time, RTI simple median movement time & RTI median 5-choice reaction time, RTI median 5-choice movement time

RTI simple error score (all), RTI total error score (5-choice)

Visual matching ability and visual recognition memory

Delayed Matching to Sample (DMS) percent correct, DMS median correct latency

DMS total errors, DMS total correct (12 s delay)

Working memory

Spatial Working Memory (SWM) between errors, SWM between errors (12 boxes), SWM strategy (6–12 boxes)

SWM total errors, SWM total errors (12 boxes)

Cognitive function

Global cognition

 

Addenbrooke Cognitive Examination-Revised (ACE-R)

Mini Mental State Examination

Device-based monitoring (thigh-worn activPAL)

Sedentary behaviour

Overall sitting timea, Overall prolonged sitting time (≥30 min), Work sitting time, Work prolonged sitting time

 

Sedentary time accumulation

Usual bout duration, Alpha (overall and work)

 

Active breaks

Active breaks (n per day overall and work)

 

Physical activity

Standing, Stepping, LPA, MVPA (all overall and during work)

 

Sleep

Total sleep time, Sleep efficiency

Sleep onset latency, Wakefulness after sleep onset

Device-based monitoring (wrist-worn Actigraph GT3X+)

Sleep

Total sleep time, Sleep efficiency

Sleep onset latency, Wakefulness after sleep onset

  1. Abbreviations: ApoE4 Apolipoprotein E4, BDNF brain-derived neurotrophic factor, BMI body mass index, CANTAB Cambridge Neuropsychological Test Automated Battery, DXA Dual X-ray absorptiometry, FMD flow-mediated dilation, HbA1c Glycosylated Haemoglobin, HDL High density lipoprotein cholesterol, Hs-CRP High-specificity C-Reactive protein, iAUC incremental area under the curve, IGF-1 insulin like growth factor 1, IL-1B interleukin-1 beta, IL-6 interleukin-6, LDL Low Density Lipoprotein Cholesterol, LPA light intensity physical activity, MVPA moderate-vigorous intensity physical activity, TNF-α Tumour necrosis factor alpha
  2. aPrimary outcomes for original OPTIMISE protocol concerning diabetes (primary endpoint = 6 months)
  3. bPrimary outcome for expanded protocol concerning dementia (primary endpoint = 12 months)