Randomized controlled study evaluating the effectiveness of a 3-week Schrothkur compared to a 3-week holiday stay in Oberstaufen specifically tailored to people suffering from type 2 diabetes mellitus
Not Applicable
- Conditions
- E11.90
- Registration Number
- DRKS00010714
- Lead Sponsor
- ehrstuhl für Public Health und Versorgungsforschung am IBE,Fachbereich Medizinische Klimatologie, Kurortmedizin und Prävention, LMU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 99
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method pre, 2 weeks, post, 3, 6 months: <br>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);<br>pre, post:<br>analysis of VNS/HRV; <br>pre, post, 6 months:<br>blood tests (C-peptide, proinsulin); <br>pre, 3, 6 months:<br>general health / health-related quality of life (SF-36); health-related behavior; <br>pre, 6 months:<br>days of sick leave (last 6 months); <br>during the 3-week Schrothkur:<br>daily documentation of physical activities, number of steps (pedometer), general condition, consumption of medicines