Targeting branched-chain amino acid oxidation to improve glycaemic control in patients with type 2 diabetes

Maastricht University0 个研究点目标入组 26 人开始时间: 2023年4月12日最近更新: 2024年7月22日

试验速览

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•Patients are able to provide signed and dated written informed consent prior to any study specific procedures, No signs of active liver or kidney malfunction, Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged = 45 and = 76 years. Males are aged = 40 years and = 76 years, Patients should have suitable veins for cannulation or repeated venipuncture, Caucasians, BMI: 25-38 kg/m2, Diagnosed with T2D at least 1.5 years before the start of the study, Relatively well-controlled T2D: HbA1c < 8.5%, Oral glucose lowering medication: metformin only or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months, No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy

•Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator, Participate in physical activity more than 3 times a week, Unstable body weight (weight gain or loss > 5 kg in the last three months), Insulin dependent T2D, Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema, Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids, Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l, Any contra-indication MRI scanning. These contra-indications include patients with e.g. the following: •Central nervous system aneurysm clip •Implanted neural stimulator •Implanted cardiac pacemaker of defibrillator •Cochlear implant •Metal containing corpora aliena in the eye or brains

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