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Table 1 Summary of assessments performed at Baseline (V0), annual pre diabetes and randomised controlled trial (RCT) visits (V1-5) of the ADDITION-Leicester study

From: Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

Visit Baseline
Screening
(v0)
Pre diabetes
annual
cohort
T2DM RCT
Year 1 (v1)
intensive/
routine
T2DM RCT
Year 2 (v2)
Intensive
T2DM RCT
Year 3 (v3)
Intensive*
/routine
T2DM RCT
Year 4(v4)
intensive
only
T2DM RCT
Year 5 (v5)
intensive/
routine
Medical Procedures:        
Blood Pressure
Electrocardiogram (ECG) √*
Foot Check - - √*
Biochemical measurements:        
75g-OGTT: Fasting & 120 min glucose - - - - -
UE, LFT, Lipid profile, HbA1c%
Renal function & urine ACR
TFT - - √*
Anthropometric measurements:        
Height
Weight
Hip/Waist circumference √*
Bioimpedence (% body fat) √*
Body Mass Index (BMI)
Screening Questionnaires*:        
Medical/family history/medications √*
Alcohol/smoking status √*
Self-reported Questionnaires:        
Findrisc[45], Cambridge risk scores[46] √*
EuroQol, EQ-5D[47] √*
WHO-5, BFI 44[48] √*
IPAQ[49], Berlin ESS[50] √*
Michigan neuropathy[51] √*
T2DM: Life Quality/treatment satisfaction - -
ADDQoL[52], DTSQ[52], W-BQ 28[52]        
Arterial measurements sub study:        
cfPWV, PCA[36, 37] - - -
Biobank storage aliquots:        
8 × 2 ml Plasma(4), serum (4), √*
Genetic Sample:        
Whole blood (EDTA) - - - - - -
  1. Key:
  2. OGTT: 75 g Oral Glucose Tolerance Test (preparation as per WHO expert consensus report -1999)
  3. UE: Biochemistry Urea & Electrolytes panel ACR: Albumin:Creatinine Ratio
  4. LFT: Liver Function Tests (Bilirubin, alanine transaminase, alkaline phosphatase, gamma glutamyl transpeptidase)
  5. HbA1c%: Glycosylated Haemoglobin
  6. Lipid profile: Total, LDL, HDL Cholesterol & Triglycerides
  7. TFT: Thyroid Function Test (Thyroid Stimulating Hormone, free thyroxine T4)
  8. cfPWV, PCA: carotid-femoral Pulse wave Velocity Pulse Contour Analysis (Photoplethysmography derived)
  9. Screening Questionnaires*: Completed during Interview with trained research nurse