Hypertension, Metabolic Syndrome, NAFLD, Obesity
Conditions
Brief summary
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.
Detailed description
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).
Interventions
Dietary treatment with or without additional motivation on more physical activity
DIETARY_SUPPLEMENTLifestyle intervention (PUFA/isomaltulose-enriched muffin)
Sponsors
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* hypertension * NAFLD * obesity * hyperuricemia * dyslipoproteinemia
Exclusion criteria
* prediabetes / overt diabetes mellitus * present cancer * systemic infection * chronic inflammatory disease * recent stroke / myocardial infarction (6 months) * pregnancy * addiction / severe psychiatric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in lipidome pattern | 6 weeks | complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention |
| reduction of blood pressure | 6 weeks | systolic and diastolic blood pressure |
| NAFLD reduction | 6 weeks | NAFLD, estimated by fatty liver index (FLI) |
| weight loss | 6 weeks | loss in body weight / BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of insulin resistance | 6 weeks | assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.) |
| improvement in quality of life | 6 weeks | standardized questionnaires |
Countries
Germany
Contacts
Primary ContactStefan Kabisch, Dr.med.
Outcome results
None listed