EUCTR2010-024487-18-SE进行中（未招募）1 期
Effects of vitamin D on beta cell function and insulin sensitivity in pre-diabetes and diabetes mellitus type 2 - EVIDENS - EVIDENS
Dept. of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital0 个研究点目标入组 44 人开始时间: 2011年4月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent obtained before any trial-related activities.
- •2.Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at screening.
- •3.Age 45 - 75 years, female or male.
- •4.BMI = 32 kg/m2.
- •5.HbA1c = 7.0 % (MonoS) or = 63 mmol/mol (IFCC) at screening.
- •6. 25-OH-Vitamin D < 75 nmol/l
- •7.Able and willing to perform tests and examinations specified in the protocol.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Previous participation in this trial. Participation is defined as randomization.
- •2.Anticipated change in dose of concomitant medication which may interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids.
- •3.Treatment with any vitamin D preparation.
- •4.Regular sun-bathing.
- •5.Sun-bathing in a southern country for = 1 week within the last 3 months.
- •6.Hypercalcemia at screening.
- •7.Hypervitamninosis D at screening.
- •8.Hyperphosphatemia at screening.
- •9.Sarcoidosis or other granulomatous disease.
- •10.Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
- •11.Impaired hepatic function defined as alanine aminotransferase (ALAT) >= three times the upper reference limit.
- •12.Impaired renal function defined as S-creatinine >133 µmol/L for males and >115 µmol/L for females.
- •13.Cardiac disease defined as:
- •a.Unstable angina pectoris
- •b.Myocardial infarction within the last 6 months
- •c.Congestive heart failure NYHA class III and IV
- •14.Cerebral stroke within the last 6 months.
- •15.Uncontrolled treated/untreated hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110mmHg).
- •16.Known or suspected allergy to trial product or any contraindications to trial product.
- •17.Cancer (except basal cell skin cancer or squamous cell skin cancer).
- •18.Anti-diabetic medication of any kind.
- •19.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- •20.Known or suspected abuse of alcohol or narcotics.
- •21.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
- •22.Any other condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results.
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