NCT00699426已完成3 期
The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.
Lise Tarnow0 个研究点目标入组 41 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- insulin secretion
研究概览
简要总结
To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.
Study Hypothesis:
- Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
- Probiotics changes the gut flora and bloodpressure
- Probiotics causes a change in inflammation and thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet
- •Males and females between 40 and 70 years
- •HbA1c between 6,0-10,0
- •Diabetes duration > 1 year
排除标准
- •Kidney disease (s-creatinine above the upper limit of normal range).
- •Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).
- •Macroalbuminuria (urinary albumin excretion of > 300 mg/day).
- •Heart failure(NYHA class lll or lV)
- •Severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)
- •Neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mM for men or <7mM for women.
- •Alcohol abuse
- •Drug abuse
- •Severe organic or metabolic diseases including cancer
- •C-peptide< 0,3 pmol/l
- •Medicine interaction
- •Treatment with insulin
- •PPI or other medications for ulcus diseases
- •Treatment with warfarin or other coumarin derivations
- •Pregnant or breastfeeding women
- •Allergy to medication used in the study
- •Participants may not participate in another clinical intervention trial
研究组 & 干预措施
Nexium + Yoghurt
Active Comparator
干预措施: nexium (Drug)
Nexium + Placebo
Placebo Comparator
干预措施: nexium (Drug)
Placebo+ Yoghurt
Placebo Comparator
干预措施: Yoghurt (Dietary Supplement)
placebo+placebo
Placebo Comparator
干预措施: placebo+placebo (Drug)
结局指标
主要结局
insulin secretion
时间窗: 1 year
次要结局
- blood pressure(1 year)
研究者
Lise Tarnow
professor
Steno Diabetes Center Copenhagen
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