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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01296308
First received: February 14, 2011
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Diabetic Neuropathy
 Other: inpatient integrative treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T2 ] [ Designated as safety issue: No ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T3 ] [ Designated as safety issue: No ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)


Secondary Outcome Measures:
  • Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    • 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)

  • Pain intensity (VAS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    100mm Visual Analogue Scale

  • Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)

  • Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Interpretation of Illness Questionnaire (Büssing et al. 2009)

  • Coping Style (AKU) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)

  • Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)

  • Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale (Diener et al. 1995)

  • Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296308

Locations
Germany
Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Gustav J. Dobos, Prof. MD University of Duisburg-Essen
  More Information

No publications provided

Responsible Party: Heidemarie Haller, MSc, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01296308     History of Changes
Other Study ID Numbers: 10-4517
Study First Received: February 14, 2011
Last Updated: July 16, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 17, 2013