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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
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Trials

ISSN: 1745-6215