2023-503424-12-00招募中4 期
Targeting branched-chain amino acid oxidation to improve glycaemic control in patients with type 2 diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Glucose levels will be measured after an overnight fast expressed in mmol/l.
研究概览
简要总结
The primary objective is to investigate if prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose levels in patients with T2D.
研究设计
- 分配方式
- Randomized
- 主要目的
- Double-blind, Placebo-controlled, Cross-over Rct
- 盲法
- Double (Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Glucose levels will be measured after an overnight fast expressed in mmol/l.
Glucose levels will be measured after an overnight fast expressed in mmol/l.
次要结局
- Glucose clearance in ml/kg determined during an OGTT at 6 weeks and glucose disposal rate (Rd) in mol/kg/min measured with the clamp at 12 weeks
- O2-flux in pmol/mg/s measured with high resolution respirometry
- insulin-stimulated change in respiratory exchange ratio (RER) with use of indirect calorimetry during the clamp
- PCr/ATP-ratio determined with phosphorus magnetic resonance spectroscopy
- Cardiac function will be measured in 2 ways: 1) ejection fraction (microL) with use of cine-MRI 2) diastolic cardiac function with use of ultrasound (transthoracic echocardiography) and will be assessed with the following parameters: • Left atrial maximum volume (ml) • Peak E-wave velocity (cm/sec) • Peak A-wave velocity (cm/sec) • Pulsed wave TDI e’velocity (cm/sec) at lateral and septal basal regions • Tricuspid regurgitation systolic jet velocity (m/sec)
- Cognitive function will be assessed in 2 ways: 1) Use of CANTAB 2) Questionnaires (Beck’s Depression Inventory and Pittsburgh Sleep Quality Index)
- Continuous glucose and ketone profile will be measure with use of the CGKM sensor
研究者
Dr. Esther Phielix
Scientific
Maastricht University
研究点 (1)
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