Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01483560
Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetes for five years or more\*
* Age 40 years or above
* 7.0 =\< HbA1c \<10.0% (53 - 86 mmol/mol)
AND 3 or more of the following ten CardioVascular Disease (CVD) risk factors:
* BMI \>27 kg/m\^2
* Current HbA1c \>8.0% (64 mmol/mol)
* Known CVD/peripheral vascular disease
* Current smoker
* Estimated glomerular filtration rate (eGFR) \<90 ml/min per 1.73 m\^3
* Confirmed micro- or macroalbuminuria \[according to local assays and reference ranges\]
* Hypertension (BP \>=140/90 millimeters of mercury (mmHg) or established on antihypertensive treatment)
* Dyslipidaemia \[total cholesterol \>=5.0 mmol/L (200 mg/dL);OR HDL cholesterol \<1.20 mmol/L (46mg/dL) \[MEN\]; OR \<1.30 mmol/L (50 mg/dL) \[WOMEN\]; or triglycerides \>=1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment)\]
* Strong family history of CVD (at least one parent, biological aunt/ uncle, or sibling with myocardial infarction or stroke aged \<60 years)
* Duration of diabetes \> 20 years
Exclusion Criteria:
* eGFR \< 45 ml/min/1.73m2
* woman of childbearing age not on effective contraception
* Pregnancy and/or lactation
* Acute coronary syndrome or Stroke/Transient Ischaemic Attack within the last three months
* NYHA stage 3 or 4 heart failure
* Significant hypoglycaemia unawareness
* Impaired cognitive function/ unable to give informed consent
* Previous carotid surgery/ inability to capture adequate carotid images
* Estimated glomerular filtration \< 45ml/min/1.73m\^2 (MDRD)
* Gastroparesis
* History of lactic acidosis
* Other contraindications to metformin (hepatic impairment, known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure or suspected tissue hypoxia)
* Any coexistent life threatening condition including prior diagnosis of cancer within two years
* History of alcohol problem or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01483560
Study Brief:
Protocol Section:
NCT01483560