E11.90
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: type 2 diabetes mellitus (medically confirmed diagnosis); HbA1c = 6,5% (48 mmol/mol); BMI = 27; participants were informed about the content and purpose of the study and gave their written informed consent
Exclusion criteria
Exclusion criteria: type 1 diabetes mellitus; severe diabetic complications (e.g. diabetic foot, kidney failure, and diabetic retinopathy); malignant tumor in the last 12 months; acute infection; liver cirrhosis; heart failure (NYHA III and IV); kidney failure (creatinine > 1,5mg%); pregnancy; mental illness (e.g. depression, psychosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| long-term glucose parameter HbA1c in conjunction with taking diabetes-related medicines at 6 months (antidiabetics, insulin) – pre, 2 weeks, post, 3, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| pre, 2 weeks, post, 3, 6 months: Body Mass Index (BMI); blood pressure; diabetes-related blood tests (fructosamine, CRP, HDL cholesterol, LDL cholesterol, triglycerides, creatinine, uric acid, TSH, GOT, GPT, GGT); well-being (World Health Organization 5-item Well-Being Index – WHO-5); general health / quality of life (EuroQol (EQ-5D-5L general health index); pre, post: analysis of VNS/HRV; pre, post, 6 months: blood tests (C-peptide, proinsulin); pre, 3, 6 months: general health / health-related quality of life (SF-36); health-related behavior; pre, 6 months: days of sick leave (last 6 months); during the 3-week Schrothkur: daily documentation of physical activities, number of steps (pedometer), general condition, consumption of medicines | — |
Countries
Germany
Contacts
Lehrstuhl für Public Health und Versorgungsforschung am IBE, Fachbereich Medizinische Klimatologie, Kurortmedizin und Prävention, LMU München