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Complementary and Integrative Therapy for Diabetic Neuropathy (CIT-DN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296308
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen

Brief Summary:
Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Diabetic Neuropathy Other: inpatient integrative treatment

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
type 2 diabetics with neuropathy Other: inpatient integrative treatment
two weeks inpatient integrative therapy: conventional medicine, traditional European and Chinese medicine (TCM), mind-body medicine, physical therapy, lifestyle modification program: nutrition advices, stress management, exercise training

Primary Outcome Measures :
  1. Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T2 ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

  2. Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T3 ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

Secondary Outcome Measures :
  1. Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ]
    • Thermal detection thresholds (CDT, WDT), thermal pain thresholds (CPT, HPT) and paradoxical heat sensations (PHS)
    • Mechanical detection threshold (MDT), mechanical pain threshold (MPT), mechanical pain sensitivity (MPS), dynamic mechanical allodynia (ALL) and wind-up ratio (WUR)
    • Vibration detection threshold (VDT)
    • Pressure pain threshold (PPT) (Rolke et al. 2006)

  2. Pain intensity (VAS) [ Time Frame: at T2 and T3 ]
    100mm Visual Analogue Scale

  3. Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ]
    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)

  4. Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ]
    Interpretation of Illness Questionnaire (Büssing et al. 2009)

  5. Coping Style (AKU) [ Time Frame: at T2 and T3 ]
    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)

  6. Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ]
    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)

  7. Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ]
    Satisfaction with Life Scale (Diener et al. 1995)

  8. Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ]
  9. Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • over 18 years old
  • diabetes mellitus type 2

Exclusion Criteria:

  • diabetes mellitus type 1
  • pregnancy
  • oncologic diseases
  • systemic neurological diseases
  • other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced)
  • other severe psychiatric or somatic comorbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296308

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Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
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Principal Investigator: Gustav J. Dobos, Prof. MD University of Duisburg-Essen
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Responsible Party: Heidemarie Haller, MSc, Universität Duisburg-Essen Identifier: NCT01296308    
Other Study ID Numbers: 10-4517
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Heidemarie Haller, Universität Duisburg-Essen:
Diabetes Mellitus, Type 2
Diabetic Neuropathy
Complementary Medicine
Alternative Medicine
Integrative Medicine
Quality of Life
Quantitative Sensory Testing
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications