Vitality Index – Platform for measurable, visible, and sustainable preventio
- Conditions
- E88.9Metabolic disorder, unspecified
- Registration Number
- DRKS00025688
- Lead Sponsor
- Vindex GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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)
- 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 Stroke,
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method