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A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.
"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.
The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.
Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity only | Active Comparator | pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal |
|
| Physical activity + Dietary treatment | Active Comparator | pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention (physical activity) | Behavioral | Dietary treatment with or without additional motivation on more physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in lipidome pattern | complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention | 6 weeks |
| reduction of blood pressure | systolic and diastolic blood pressure | 6 weeks |
| NAFLD reduction | NAFLD, estimated by fatty liver index (FLI) | 6 weeks |
| weight loss | loss in body weight / BMI | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of insulin resistance | assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.) | 6 weeks |
| improvement in quality of life | standardized questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Kabisch, Dr.med. | Contact | 030 450 514 429 | stefan.kabisch@dife.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institut for Human Nutrition; Department for Clinical Nutrition | Not yet recruiting | Bergholz-Rehbrücke | Brandenburg | 14458 | Germany |
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| Lifestyle intervention (PUFA/isomaltulose-enriched muffin) | Dietary Supplement |
|
| 6 weeks |
| DIfE (German Institute for Human Nutrition) | Recruiting | Berlin | 12203 | Germany |
|
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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