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Table 1 Inclusion and exclusion criteria

From: Rationale and design of the randomised controlled trial to assess the impact of liraglutide on cardiac function and structure in young adults with type 2 diabetes (the LYDIA study)

Inclusion criteria

Capacity to provide informed consent before any trial-related activities

Individuals aged 18–50 years inclusive

Established T2DM

BMI ≥30 kg/m2 (≥27 kg/m2 for South Asians or other BME populations)

On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for ≥ 3 months

No prescribed thiazolidinediones within the last 3 months

An HbA1c value of greater than or equal to 6.5 % and less than 10 % (venous blood)

Exclusion criteria

<18 years old

Absolute contraindications to MRI

Type 1 diabetes (identified through C-peptide analysis in cases of diagnostic uncertainty)

Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods

Suffer from terminal illness

Have impaired renal function (eGFR <30 ml/min/1.73 m2)

Impaired liver function (ALT ≥2.5 times upper limit of normal)

Known Hepatitis B or Hepatitis C

Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the investigator

Recurrent major hypoglycaemia as judged by the investigator

Known or suspected allergy to the trial products

Known or suspected thyroid disease (such as thyroid nodule or thyroid cancer)

Receipt of any investigational drug within 4 months prior to this trial

Have severe and enduring mental health problems

Are not primarily responsible for their own care