Trial document





This trial has been registered retrospectively.
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  DRKS00010714

Trial Description

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Title

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

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Trial Acronym

-

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URL of the Trial

http://-

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Brief Summary in Lay Language

In the case of early-stage type 2 diabetes mellitus lifestyle changes such as more physical activity, a healthy diet, and, if necessary, weight reduction can often be a successful treatment. This is where the Schrothkur comes in. The calorie-reduced, mainly basic, fat- and animal protein-free Schroth’s Diet along with changes in the daily intake of liquids, the change of heat and cold, and the change of motion and rest leads to intensified metabolism.
The effects of a Schrothkur can be recognized after two weeks: reduced body weight, reduced strain on the back and joints, increased pleasure of physical movement, decreased blood pressure, and increased vitality. However, according to diabetologists and spa physicians the Schrothkur is most effective in week three where, in addition to further reduction in weight, improved cholesterol, blood glucose levels, blood lipid and liver values can be observed. The often considerable weight loss is actually a minor matter, but ideal for people with diabetes to reduce the required dose of antidiabetics, insulin, and antihypertensives. This can be a starting point for sustainable change in lifestyle.
These observed effects, which have been frequently reported by spa guests with type 2 diabetes mellitus and by their treating physicians from Oberstaufen have now been scientifically validated. For this, it was assumed that with a 3-week Schrothkur for diabetics better results are achieved than with a 3-week holiday stay directed specially at diabetics.

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Brief Summary in Scientific Language

The Schrothkur is a naturopathic treatment combining a low calorie, relatively high-carbohydrate and mainly basic, fat- and animal protein-free diet (Schroth’s Diet). It also includes a daily change between a higher or lower intake of liquids (Schroth's Drinking Regulation) and a daily alteration in body activities between days of high activity and days of rest. Cold and damp body wrap is given daily in the early morning (Schroth's Body Pack). The aim is to intensify metabolism. The Schrothkur will always be carried out in specialised spa facilities under medical supervision.
The main focus of the Schrothkur is on regulation of disturbances of all kinds. It aims to strengthen self-healing and the body's defenses, and promotes well-being, performance, fitness and vitality. The Schrothkur is suitable both for prevention as well as for the treatment of a variety of already manifest diseases including metabolic disorders (e.g. obesity, type 2 diabetes mellitus, and metabolic syndrome).
The results of a pilot-study by the Mathias Hochschule Rheine (2010/2011) revealed that with a Schrothkur in people with type 2 diabetes mellitus can lead to metabolic improvement, when compared to that achieved by the participation of the patient in one of the established structured treatment and teaching programs.
However, this study has limitations, as all study participants have deliberately opted for treatment and there was no control group. In order to better assess the impact of the Schrothkur in people with type 2 diabetes mellitus a randomized controlled study with 6-month follow-up has now been carried out.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010714
  •   2016/06/22
  •   [---]*
  •   yes
  •   Approved
  •   312-14, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E11.90 -  [generalization E11.9: Non-insulin-dependent diabetes mellitus; Without complications]
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Interventions/Observational Groups

  •   1. Schrothkur:
    3-week Schrothkur with four therapeutic elements (1) Schroth’s Diet (therapeutic fasting: light food, calorie-reduced, mainly basic, fat- and animal protein-free, almost salt-free), (2) Schroth’s Body Pack (cold and damp body wrap to which the body responds with increased temperature and the excretion of metabolic residues) (15 times approx. 2 hours in the early morning), (3) Schroth's Drinking Regulation (change of drinking days and dry days, i.e. change of the daily amount of fluid intake, which should differ significantly on drinking days and dry days and which is determined by the spa physician individually by taking into account possible pre-existing diseases; Kur drinks are herbal tea, mineral water, fruit juices, and, only by doctor's prescription, small amounts of dry wine), (4) daily change in higher body activities and rest days (drinking days are days with higher body activities (moderate sports activities such as hiking, golfing, Nordic skiing); dry days are rest days (relaxation exercises, massages, walks, resting, reading etc.);
    participation in the following events (obligatory):
    introductory talk by spa physician (1 hour); nutrition lecture (2 hours); "Gentle hiking" with a climate therapist (8 times; 2 hours); exchange of experience in the group moderated by a diabetes counselor twice a week (1.5 hours each);
    each participant will receive a pedometer for checking his/her daily exercise habits and to create an incentive for additional physical activity;
    a further optional activity includes personal meetings with the diabetes counselor
  •   2. Holiday stay directed specially at diabetics:
    3-week holiday stay specifically tailored to people suffering from type 2 diabetes mellitus and in compliance with the “Practical recommendations for nutrition and exercise” of the German Diabetes Society (DDG) and the German Society for Nutrition (DGE)” (the menus were coordinated with the diabetologist and the diabetes counselor on site); it is also recommended to use the options for relaxation offered by the hotel; participants are encouraged to use the opportunities for physical activity offered by the climatic health resort of Oberstaufen and the surrounding countryside;
    participation in the following events (obligatory):
    introductory talk by diabetes counselor (2 hours); nutrition lecture (2 hours); exchange of experience in the group moderated by a diabetes counselor twice a week (1.5 hours each);
    each participant will receive a pedometer for checking his/her daily exercise habits and to create an incentive for additional physical activity;
    a further optional activity includes personal meetings with the diabetes counselor
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

long-term glucose parameter HbA1c in conjunction with taking diabetes-related medicines at 6 months (antidiabetics, insulin) – pre, 2 weeks, post, 3, 6 months

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/09/16
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   70   Years
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Additional 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

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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)

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Addresses

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    • Lehrstuhl für Public Health und Versorgungsforschung am IBE,Fachbereich Medizinische Klimatologie, Kurortmedizin und Prävention, LMU München
    • Ms.  Prof. Dr. Dr.  Angela  Schuh 
    • Elisabeth-Winterhalter-Weg 6
    • 81377  München
    • Germany
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    • Praktische Ärztin
    • Ms.  Dr. med.  Susanne  Neuy 
    • Weißachstraße 10
    • 87534  Oberstaufen/Allgäu
    • Germany
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    • Lehrstuhl für Public Health und Versorgungsforschung am IBE, Fachbereich Medizinische Klimatologie, Kurortmedizin und Prävention, LMU München
    • Ms.  Dr.  Marita  Stier-Jarmer 
    • Elisabeth-Winterhalter-Weg 6
    • 81377  München
    • Germany
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    • Lehrstuhl für Public Health und Versorgungsforschung am IBE, Fachbereich Medizinische Klimatologie, Kurortmedizin und Prävention, LMU München
    • Mr.  Dr.  Dieter  Frisch 
    • Elisabeth-Winterhalter-Weg 6
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Staatsministerium für Gesundheit und Pflege (StMGP)
    • Haidenauplatz 1
    • 81667  München
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/02
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* This entry means the parameter is not applicable or has not been set.