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Complementary and Integrative Therapy for Diabetic Neuropathy

NCT ID: NCT01296308

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Diabetic Neuropathy

Keywords

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Diabetes Mellitus, Type 2 Diabetic Neuropathy Complementary Medicine Alternative Medicine Integrative Medicine Quality of Life Quantitative Sensory Testing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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type 2 diabetics with neuropathy

inpatient integrative treatment

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Heidemarie Haller

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav J. Dobos, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen

Locations

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Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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10-4517

Identifier Type: -

Identifier Source: org_study_id