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Clinical Trials/NCT01296308
NCT01296308
Completed
N/A

Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Universität Duisburg-Essen1 site in 1 country6 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Universität Duisburg-Essen
Enrollment
6
Locations
1
Primary Endpoint
Neuropathy-related Quality of Life (QOL-DN)
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
July 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heidemarie Haller

MSc

Universität Duisburg-Essen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Neuropathy-related Quality of Life (QOL-DN)

Time Frame: at T3

Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

Secondary Outcomes

  • Quantitative Sensory Testing (QST)(at T2 and T3)
  • Pain intensity (VAS)(at T2 and T3)
  • Control Beliefs (MHLC / short form)(at T2 and T3)
  • Interpretation of Illness (IIQ)(at T2 and T3)
  • Coping Style (AKU)(at T2 and T3)
  • Anxiety and Depression (HADS)(at T2 and T3)
  • Life Satisfaction (SWLS)(at T2 and T3)
  • Blood sugar Level (HbA1c)(at T2 and T3)
  • Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)(at T2 and T3)

Study Sites (1)

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