ACTRN12623001277639
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- type 1 diabetes
- Sponsor
- Garvan Institute of Medical Research
- Enrollment
- 76
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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):
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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