NL-OMON55800已完成不适用
Targeting the secondary bile acid glycodeoxycholic acid as therapeutic strategy in type 2 diabetes mellitus. - TRADE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •- Male, Specific inclusion criteria for the healthy lean subject group:
- •- BMI between 18,5-25 kg/m2 or a BMI between 25 and 30 kg/m2 and waist
- •circumference 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
- •- 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
排除标准
- •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,
- •- 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
研究者
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