Trial document





This trial has been registered retrospectively.
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  DRKS00004715

Trial Description

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Title

Effectiveness of complementary integrative therapy with fasting in patients with diabetes mellitus type 2 and metabolic syndrome: A randomized controlled pilot study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To evaluate the effectiveness of the complementary integrative therapy program (nutrition therapy, fasting, mind-body medicine) compared to conventional therapy in outpatients with diabetes mellitus type 2 and metabolic syndrome.

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Brief Summary in Scientific Language

The aim of the pilot study is to evaluate the effect of an additive applied complementary integrative therapy program (nutrition therapy, fasting and mind body medicine), compared to conventional treated group for outpatients with diabetes mellitus type 2 and metabolic syndrome.

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Organizational Data

  •   DRKS00004715
  •   2013/06/03
  •   [---]*
  •   yes
  •   Approved
  •   EA4/125/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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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]
  •   E88.9 -  Metabolic disorder, unspecified
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Interventions/Observational Groups

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    Subjects from group 1 receive outpatient complementary integrative therapy with nutrition therapy (fasting for 7 days) and mind body medicine for 12 weeks. At the beginning the subjects start with 7 days modified fasting. Then nutrition and mind-body medicine group trainings follow.

  •   Subjects from group 2 (control group) will be treated conventionally. The conventional treatment includes drug therapy and lifestyle consulting according to the guidelines. After the last study visit all subjects of the control group will receive an offer to fasting / complementary therapy.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change in long-term blood sugar (HbA1c) using a blood collection: baseline (day 0) versus endpoint (12 weeks).

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Secondary Outcome

- HOMA score for insulin sensitivity
- Quality of Life (WHO-5)
- Overall assessment of efficacy and tolerability (Likert scale) by the patient
- Weight, abdominal girth
- HbA1 C, glucose and insulin levels
- Blood pressure, systolic / diastolic
- Blood lipids (Chol LDL-C, HDL-C, TG): baseline (day 0) versus endpoint (12 weeks).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/01/30
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   70   Years
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Additional Inclusion Criteria

1. A signed consent form
2. Age 25 - 70 years
3. Existence of a specialist secure type 2 diabetes mellitus (HbA1c> 7%)
4. Maximum basal insulin 40 IU
5. BMI > 25Kg/cm ²
6. Waist cm men > 94, women > 80 cm
7. Patient is intellectually and linguistically able to understand the significance of the study

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Exclusion Criteria


1. Pregnancy, lactation period
2. Diabetes mellitus type-1 with basal-bolus insulin therapy
3. Lack of insulin C-peptide> 1.2 ng / dl
4. Hypotension <100/60 mmHg
5. Myocardial infarction, pulmonary embolism or stroke in the three last months
6. Renal insufficiency stage III
7. Heart failure NYHA stage III
8. Diabetic retinopathy
9. PAOD stage> 2b
10. Diabetic foot syndrome > Wagner 1, A Armstrong
11. Manifest eating disorder or binge-eating disorder
12. Serious acute somatic disease or infectious disease
13. Severe or acute mental illness
14. Simultaneous participation in another study

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Addresses

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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Mr.  Prof. Dr. med  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • diR Schwerpunktpraxis Diabetes & Rheuma Wilmersdorf
    • Ms.  Badri  Sadraie 
    • Mecklenburgische Strasse 20
    • 10713  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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