E88.9
Conditions
Interventions
Group 1: Training group (mei:do concept: physical training, lifestyle adaptation coaching). The physical training includes the components flexibility training to strengthen the joints, muscle length t
Sponsors
Vindex GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to identify possible type II diabetes markers. For this purpose, the following data will be collected at the first visit and subsequently at 3-month intervals: Waist circumference, waist-to-hip ratio, CBC, coagulation, blood gas, clinical chemistry (e.g., protein, insulin), hormone levels, vitamins, metabolites, immune status, retinal angiography, exercise capacity by spiroergometry, cortisol, colon microbiome, satisfaction, health and motivation questionnaires, and hand strength. At the first and at the 6-month visit, general fitness tests and a cognition test are also conducted. The following data are collected weekly: Weight, BMI, blood pressure, body fat, body temperature, blood oxygen saturation, glucose, amount of sleep, activity profile, heart rate variability, voice profile, antioxidants, and skin conductance. Some patients are randomized into additional groups where gait pattern, epigenetics, and telomere lengths are analyzed, as well as a more detailed sleep analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study goals are the development of a vitality index with the identified markers, the verification of the effectivity of the mei:do training concept in patients with metabolic syndrome, and the investigation of the changes and correlations of type-II-diabetes markers. | — |
Countries
Germany
Outcome results
None listed