Diabetes Diabetes Mellitus
Conditions
Interventions
During a 12 week period patients will participate in a full exercise program.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes 2. Male or female (post-menopausal) 3. Age above 45 years and below 70 years 4. BMI >30 kg/m2 5. Metformine monotherapie (no insulin or other glucose lowering medication) 6. Stable medication use 7. Stable tension regulation (with or without medication) 8. Stable body weight during 6 months before enrolment in the study (
Exclusion criteria
Exclusion criteria: 1. A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation) 2. Severe-very severe lung emphysema (GOLD stage III-IV) 3. Use of any antibiotics or proton pump inhibitor (PPI) in the past three months 4. Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin) 5. Use of a platelet inhibitor or cumarin derivate during 6. Subjects participated in a lifestyle programme in the past 6 months (diet or exercise) 7. Contraindications of iloprost (ilomedine®): increased risk of bleeding; severe coronary artery disease or instable AP; heart failure (NYHA class II-IV); severe arrhythmias; suspected left decompensation; hypersensitivity to the active substance or to any of the excipients 8. Contraindications of insulin(NovoRapid®): hypersensitivity to the active substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: change in gut microbiota composition | — |
Secondary
| Measure | Time frame |
|---|---|
| * Whole-body Iinsulin sensitivity: by means of hyperinsulinemic-euglycemic clamp * Muscle microcirculation: Insulin-mediated capillary recruitment by means of contrast-enhanced ultrasound (CEUS), * Needle skeletal muscle and adipose tissue biopsies to assess: protein and gene expression of insulin signalling proteins, lipid content and PVAT morphology muscle biopsy * Markers of inflammation: CRP, LPS serum, cytokines (IL1, IL 6, IL-8 and TNF-*) * Metabolism: Resting energy expenditure (resting metabolic rate) and % oxidation of macronutrients by means of indirect calorimetry (Quark®) (REE), Bio Impedance Analysis (BIA) * 24 hour urine samples * Metabolic and humoral biomarkers (plasma glucose, HbA1c, FFA; catecholamines) * Body anthropometrics (weight, height, BMI, waist and hip circumferences, fat %) * Physical activity energy expenditure * Questionnaires: RPE-scale, PACE-score | — |
Countries
Netherlands
Outcome results
None listed