DRKS00025688招募中未知
Vitality Index – Platform for measurable, visible, and sustainable prevention - Vindex_01
Vindex GmbH0 个研究点目标入组 90 人开始时间: 2021年6月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Patients with the correct age with metabolic syndrome. The metabolic syndrome is defined by a waist of >94cm (men) or >80cm (women) and the occurrence of at least two of the following criteria:
- •- obesity grade I (BMI = 30)
- •- HbA1C ˜ 6%
- •- Chronically increased fasting blood sugar (>100 mg/dl)
- •- Increased blood pressure (>130/85 mmHg)
- •- Increased triglyceride (>150 mg/dl)
- •- Low HDL (<50 mg/dl in women, <40 mg/dl in men)
排除标准
- •- Any antidiabetic therapy within the last 3 months
- •- Blood glucose (fasting) > 250mg/dl
- •- Unintentional weight loss > 5kg within the last 3 months
- •- Pre-existing conditions:
- •o Pancreatitis,
- •o Pancreatectomy,
- •o Gastrointestinal surgery (excluding appendectomy),
- •o Inflammatory bowel disease,
- •o Reflux disease requiring therapy within last 6 months.
- •- Within the last 6 months:
- •o Heart attack,
- •o hospitalization due to heart failure
- •- Participation in other studies
- •- Blood pressure >180/95mmHg
- •- Use of anticoagulant medications, with the exception of prophylactic use of acetylsalicylic acid
- •- Untreated or recent onset of cardiac arrhythmias
- •- Acute inflammation of the heart
- •- Occlusion of a pulmonary vessel
- •- Inadequately treated asthma
- •- Acute febrile infections
- •- Blood or plasma transfusion within the past 3 months, hemoglobinopathies, hemolytic anemia
- •- Regular systemic corticosteroids for > 7 days within the last 3 months
- •- Creatinine > 1.4 in women and > 1.5 in men
- •- Severe musculoskeletal limitations or injuries as judged by the investigator
- •- Aphakic patients and those with ocular disease
- •- Other chronic, unstable medical conditions as assessed by the investigator
- •- Chronic thyroid dysfunction at the discretion of the investigator
- •- Pregnant, breastfeeding women and women planning to become pregnant
- •- Illiteracy and German language level below C1
- •- Alcohol/drug addicts
- •- Incapable of giving consent according to MPG § 20 para. 2 sentence 1 no. 1
- •Prohibited medication during the study:
- •- Systemic corticoids for > 7 days
- •- Antidiabetic drugs orally or systemically
- •- Dietary preparations
研究者
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