Diabetes Mellitus, Type 2CIT-DNNCT01296308
Complementary and Integrative Therapy for Diabetic Neuropathy
An observational study of Diabetes Mellitus, Type 2 and Diabetic Neuropathy, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Neuropathy
- What is being tested?
- inpatient integrative treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- over 18 years old
- diabetes mellitus type 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Neuropathy
- Being tested
- inpatient integrative treatment
- Keywords
- Diabetes Mellitus, Type 2, Diabetic Neuropathy, Complementary Medicine, Alternative Medicine, Integrative Medicine, Quality of Life, Quantitative Sensory Testing
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient integrative treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetics with neuropathy | Not described Receives: Other: inpatient integrative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathy-related Quality of Life (QOL-DN)
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Measured: at T2
Neuropathy-related Quality of Life (QOL-DN)
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Measured: at T3
Secondary outcomes (9)
Quantitative Sensory Testing (QST)
- 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)
Measured: at T2 and T3
Pain intensity (VAS)
100mm Visual Analogue Scale
Measured: at T2 and T3
Control Beliefs (MHLC / short form)
Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
Measured: at T2 and T3
Interpretation of Illness (IIQ)
Interpretation of Illness Questionnaire (Büssing et al. 2009)
Measured: at T2 and T3
Coping Style (AKU)
Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
Measured: at T2 and T3
Anxiety and Depression (HADS)
Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
Measured: at T2 and T3
Life Satisfaction (SWLS)
Satisfaction with Life Scale (Diener et al. 1995)
Measured: at T2 and T3
Blood sugar Level (HbA1c)
Measured: at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)
Measured: at T2 and T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav J. Dobos, Prof. MD, Principal investigator, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296308
- Sponsor's protocol ID
- 10-4517
- Acronym
- CIT-DN
- Status last verified
- Jul 2012
- First submitted
- 14 Feb 2011
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
- ClinicalTrials.gov ID
- NCT01296308
- Acronym / sponsor ID
- CIT-DN / 10-4517
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Neuropathy
- Keywords
- Diabetes Mellitus, Type 2, Diabetic Neuropathy, Complementary Medicine, Alternative Medicine, Integrative Medicine, Quality of Life, Quantitative Sensory Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetics with neuropathy | – | Other: inpatient integrative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- over 18 years old
- diabetes mellitus type 2
Key exclusion criteria (6 listed)
- diabetes mellitus type 1
- pregnancy
- oncologic diseases
- systemic neurological diseases
- other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inpatient integrative treatmenttwo 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 | Other | type 2 diabetics with neuropathy |
Primary outcome
Neuropathy-related Quality of Life (QOL-DN)
Time frame: at T2
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Neuropathy-related Quality of Life (QOL-DN)
Time frame: at T3
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
9 secondary outcomes
Quantitative Sensory Testing (QST)
Time frame: at T2 and T3
Pain intensity (VAS)
Time frame: at T2 and T3
Control Beliefs (MHLC / short form)
Time frame: at T2 and T3
Interpretation of Illness (IIQ)
Time frame: at T2 and T3
Coping Style (AKU)
Time frame: at T2 and T3
Anxiety and Depression (HADS)
Time frame: at T2 and T3
Life Satisfaction (SWLS)
Time frame: at T2 and T3
Blood sugar Level (HbA1c)
Time frame: at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)
Time frame: at T2 and T3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav J. Dobos, Prof. MD principal investigator
University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetic Neuropathy, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathy-related Quality of Life (QOL-DN) (time frame: at T2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012; AzTrials last refreshed its copy on 30 Oct 2026.