Evaluating the efficacy of REducing cardiometabolic risk with SEmaglutide by measuring arterial stiffness in overweight and obese adults aged over 25 with Type 1 diabetes

Garvan Institute of Medical Research0 个研究点目标入组 76 人开始时间: 2023年12月7日最近更新: 2024年6月3日

适应症

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•Main study:
•1. type 1 diabetes of greater than or equal to 2 years duration
•2. body mass index greater than or equal to 25 kg/m2
•3. HbA1c greater than or equal to 7.0%
•4. at least one cardiovascular risk factor:
•- history of microalbuminuria [urinary albumin:creatinine ratio greater than 2.5 mg/mmol for males, greater than 3.5 mg/mmol for females]
•- hypertension [Blood pressure (BP) greater than 140/90mmHg] or anti-hypertensive treatment
•- hyperlipidemia [Total Cholesterol(TC):High Density Lipoprotein (HDL) ratio greater than 6] or lipid lowering therapy
•- current smoking
•Sub-study (Pancreatic hormones and carotid femoral pulse wave velocity only in people without diabetes to provide comparative data for baseline measures in type 1 diabetes group):
•1. body mass index greater than or equal to 25 kg/m2

•Main and sub-study:
•1. treatment with a GLP1 receptor agonist, metformin or SGLT2 inhibitor in the last 3 months
•2. current or planned treatment with medications that affect glucose metabolism (i.e. glucocorticoids, antipsychotics, immunosuppressants)
•3. previous or planned bariatric surgery during study period
•4. diabetic ketoacidosis or severe hypoglycaemia in the last 12 months
•5. eGFR less than 45 ml/min/1.73m2
•6. evidence of significant liver disease (known cirrhosis, LFTs greater than 3x upper limit of normal)
•7. known gastroparesis
•8. history of pancreatitis or cholecystitis
•9. pregnant, breastfeeding or female of childbearing potential not using adequate contraception
•10. coronary event or stroke in the last 3 months
•11. active or untreated proliferative diabetic retinopathy
•12. personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
•13. previous adverse reaction to semaglutide necessitating discontinuation
•Sub-study:
•1. diabetes mellitus

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