owering Branched-Chain Amino Acids as a New Strategy to Treat Diabetes - NaPB as tool to boost BCAA oxidation

Maastricht University0 个研究点目标入组 16 人开始时间: 2018年11月23日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1.Patients are able to provide signed and dated written informed consent prior to any study specific procedures
•2.Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged = 45 and = 70 years. Males are aged = 40 years and = 70 years
•3.Patients should have suitable veins for cannulation or repeated venipuncture
•4.Caucasians
•5.BMI: 28-38 kg/m2
•6.Diagnosed with T2D at least 1.5 years before the start of the study
•7.Relatively well-controlled T2D: HbA1c < 8.5%
•8.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
•9.No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
•10.No signs of active liver or kidney malfunction
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•1.Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
•2.Participate in physical activity more than 3 times a week
•3.Unstable body weight (weight gain or loss > 5 kg in the last three months)
•4.Insulin dependent T2D
•5.Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
•6.Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
•8.Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
•A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrollment.

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