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Table 1 Study flow chart

From: The effect of circuit resistance training, empagliflozin or “vegeterranean diet” on physical and metabolic function in older subjects with type 2 diabetes: a study protocol for a randomized control trial (CEV-65 trial)

 

Screening

Baseline day (W0–1)e

Familiarization of protocolb (W0–2)

After 1 week (W1)

After 6 weeks (W6)

After 10 weeksc (W10)

After 16 weeks (W16)

After 20 weeks (W20)

On site visit number

1

2

3

4

5

6

7

8

Informed consent

X

       

Eligibility criteria form

X

       

Medical discharge and list of drugs from primary physician + physical activity confirmation letter

X

       

Blood examinations from last 3 months (for eligibility)

X

       

Physical examination for vital signs by study physician

X

    

X

 

X

Screening blood and urine tests (biochemistry and endocrinology):

a) Urine microalbumin, sodium, creatinine, free cortisol)

b) TSH, FT4

c) 25 OH vitamin D

X

       

Demographic details, questions on health status, lifestyle using MABAT questionnaire

X

       

Functional and physical activity questionnaires

X

       

Food frequency questionnaire

X

       

Guidance about diabetes diary

X

       

Drug guidance for drug arm only

 

X

      

Dietary guidance for diet arm only

  

X

X

X

 

X

 

CRT guidance for CRT arm only

  

X

X

    

CRT guidance for drug and diet arms

     

X

  

Height

 

X

      

Body weight

 

X

   

X

 

X

Body circumferences

 

X

   

X

 

X

Body fat %, lean and muscle mass assessments using BIA method

 

X

   

X

 

X

Resting blood pressure

 

X

   

X

 

X

Resting energy expenditure

 

X

   

X

 

X

24 h blood pressure monitoring

 

X

   

X

 

X

Fasting plasma glucose and HbA1C

 

X

   

X

 

X

Testosterone (T) and bioavailable T

 

X

   

X

 

X

HOMA- Insulin X glucose/23.5

 

X

   

X

 

X

LH, FSH, Estradiol

 

X

   

X

 

X

Diabetes diary (self-monitoring glucose levels, change in drugs)

 

X

   

X

 

X

Functional and frailty tests

X

    

X

 

X

CRT diary (report on training days and performance)

  

X

X

X

X

X

X

Left of tablets count of drugs

     

X

 

X

Adherence to MedD

X

    

X

 

X

Food diary – 3 days

  

X

  

X

 

X

Quality of life

X

    

X

 

X

Phone calls (adverse events monitoring)

  

X

X

X

X

X

X

Encouragement using phone calls

  

X

X

X

X

X

X

  1. aAllocation concealment until the end of baseline day – then allocation is introduced both to researcher and the subjects. Subjects allocated to SGLT-2 would meet physician at the end of the day for instruction of the use of the drug and will be supplied with drugs for 20 weeks). Subjects allocated to Diet and CRT groups will make an appointment for the following week (familiarization)
  2. bFor diet subjects – on site visit and for CRT subjects – familiarization at their homes
  3. cAt this week CRT group will finish the study and SGLTT-2 and V-Med add CRT on top of their current intervention. Familiarization of the CRT will be performed on the same week.
  4. Abbreviations: BIA Bioelectrical Impedance Analysis, BMI Body Mass Index, CRT Circuit Resistance Training, HbA1c Hemoglobin A1C, MedD Mediterranean Diet
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