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Table 7 LIONESS trial flowchart of visits and procedures

From: Design and rationale for the randomised, double-blinded, placebo-controlled Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS) crossover study

 

Screening visit

Commence trial (Week 0)

Study visit (Week 1)

Exercise test 1 (Week 2)

Exercise test 2 (Week 3)

Study visit (Week 4)

Exercise test 3 (Week 5)

Exercise test 4 (Week 6)

Obtain informed consent, issue safety information card and patient diary

Yes

-

-

-

-

-

-

-

Randomisation to study agents

Yes

Perform first self-administration of study agent

-

-

-

-

-

-

Issue 7-day course of blinded study agent

-

Yes

Yes

Yes

Yes

Yes

Yes

Stop all study medication

Check study drug compliance

-

-

Yes

Yes

Yes

Yes

Yes

Yes

Withdraw protocol-mandated pre-existing patient medication

Tutorial and commence withdrawal

Complete withdrawal

-

-

-

-

-

Recommence pre-existing patient medication

Home Blood Glucose Monitoring

Tutorial and issue equipment

-

Record data from patient diary

Record data from patient diary

Record data from patient diary

Record data from patient diary

Record data from patient diary

Record data from patient diary

Physical examination

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Height measurement

Yes

-

-

-

-

-

-

-

Weight measurement

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Blood pressure measurement

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Electrocardiogram

Yes

-

-

-

-

-

-

-

Pre-specified blood tests

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Perform supervised exercise tolerance test (ETT)

Yes (if recent ETT unavailable)

-

-

Yes

Yes

-

Yes

Yes

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Cardiovascular Diabetology

ISSN: 1475-2840