Cardiac remodeling Circulatory System
Conditions
Interventions
The analysis is part of the B-SMART Study (Berlin Study of Metabolomics in Adiposity and its Role for Successful Therapy) (ClinicalTrials.gov Identifier: NCT00956566). This prospective randomized stud
Sponsors
Charité - University Medicine Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 and 27 kg/m² 3. No medication except contraceptives or L-thyroxine 4. Discontinuation of a chronic medication must be medically justifiable because improvement in the condition for which the medication is being taken can be expected through weight loss
Exclusion criteria
Exclusion criteria: 1. Pregnancy/lactation 2. Diseases or functional disorders that, in the opinion of the investigator, preclude participation in a clinical trial 3. Manifest endocrinological or metabolic diseases requiring treatment (diabetes mellitus, hypo- and hyperthyroidism, Cushing's syndrome, M. Cushing syndrome, Cushing's disease); normal TSH with L-thyroxine use is acceptable 4. Manifest cardiovascular diseases requiring treatment (hypertension like RR > 160/95 mmHg or > two medications; coronary artery disease or previous myocardial infarction; cerebral ischemia or apoplexy; clinically significant diseases of the blood vessels (stenoses of the vessels supplying the brain; renal artery stenoses, pAVK) 5. Diseases of the kidney, liver, or gastrointestinal tract that require treatment and intestinal tract that require chronic medication 6. Significant neurological or psychiatric disorders (depression, epilepsy, schizophrenia, bulimia nervosa) 7. History of bariatric surgery 8. Known or proven abuse of medication, drugs or alcohol 9. Tumor diseases; postoperative phase 10. Acute and chronic infections 11. Incapacity or circumstances that do not allow the patient to fully understand the nature, meaning, and implications of this study 12. Metal implants and other contraindications by performing MRI (body weight > 130 kg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial deformation is measured by applying cardiac magnetic resonance feature tracking software (CVI42 (Version 4.1.2, Circle Cardiovascular Imaging Inc.)) at baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Left atrial volume, right atrial volume, right ventricular volume, and left ventricular mass/volume ratio are measured at baseline and after 6 months. Units for volume are ml. Unit for left ventricular mass/volume ratio is g/ml. All secondary measures are collected by cardiac magnetic resonance data and are quantified by applying (CVI42 (Version 4.1.2, Circle Cardiovascular Imaging Inc.)) | — |
Countries
Germany
Outcome results
None listed