Targeting the secondary bile acid glycodeoxycholic acid as therapeutic strategy in type 2 diabetes mellitus. - TRADE

Academic Medical Center0 个研究点目标入组 40 人开始时间: 2017年6月26日最近更新: 2018年6月5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:
•- Ability to provide informed consent
•- Age: 18 years or older at the time of signing the informed consent
•Specific inclusion criteria for the healthy lean subject group:
•- BMI between 18,5-25 kg/m2 or BMI between 25 and 30 kg/m2 with a waist circumference between between 79 cm and 94 cm
•- HOMA-IR index: = 2.0 (measured as fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135)
•Specific inclusion criteria for the type 2 diabetes mellitus (T2D) patient group:
•- T2D treated with diet and/or medication only (medication not changed in the past 3 months)
•- HbA1c 53-64 mmol/mol
•- BMI above 25 kg/m2
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- Use of medication that interferes with bile acid metabolism (colesevelam, colestimide, ursodeoxycholic acid).
•- Diabetes treatment with dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists or insulin
•- Hypercholesterolemia treatment with statins or fibrates unless on a stable dose for at least 3 months prior to screening
•- Use of nicotinic acid or derivates of nicotinic acid within 4 weeks prior to screening
•- Use of other drugs such as the following: vitamin K antagonists, ciclosporine, antacids containing aluminium hydroxide or aluminium oxide
•- Cholecystectomy
•- Gastro-intestinal disorders, including gallstone disease
•- Nefropathy checked by blood chemistry (creatinine, eGFR)
•- Liver disease checked by blood chemistry (ASAT, ALAT, GGT, AF, bilirubin)
•- Weight increase or decrease >10% in previous 3 months
•- Alcohol use >3 units/day
•- Tobacco use
•- XTC, cannabis, cocaine or opioids abuse
•- Likely to leave the study before its completion
•- Participation in other intervention studies

发起方

Academic Medical Center