AlbuminuriaHEIDISNCT00263419
Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
A study testing Mindfulness Based Stress Reduction in people with Albuminuria and Diabetes Mellitus, Type 2, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Albuminuria, Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jun 2012
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Type 2
- Albuminuria
- Age 30-70
Who cannot join
- Diabetes duration < 3 years
- Preexisting non-diabetic kidney
- Psychiatric disorders
- Alcohol or drug abuse
- Malignant tumors or hematologic disorders
- Heart failure NYHA III-IV
- Acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, University of Heidelberg
Heidelberg, 69120
About this study
Official title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.
Read the detailed description
Patients with type 2 diabetes and increased albumin excretion have an increased risk of renal failure and cardiovascular events. It has recently been shown, that psychosocial stress is an additional major risk factor contributing to the increased risk of cardiac events. However, it is not clear, whether a structured stress-relief training of patients reduces the risk of micro- and macrovascular damage in type 2 diabetes.
Comparisons: Conventional treatment of diabetes according to national guidelines is compared to conventional treatment plus structured stress relief management training.
- Being tested
- Mindfulness Based Stress Reduction
- Keywords
- Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress
- Medical subject headings
- Albuminuria, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Also called Heidelberger Diabetes and Stress (HEIDIS) - Study
8 weeks mindfulness based stress reduction (MBSR) based on body and meditation practices that aims at cultivation of openness, awareness of the present moment and acceptance of all internal and external experiences. It is assumed that this allows to act more reflectively rather than impulsively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of albuminuria
Measured: 1,2,3,4 and 5 year
Secondary outcomes (7)
Mortality
Measured: 3,4 and 5 years
Late diabetic complications (micro-macrovascular)
Measured: 1,2,3,4 and 5 years
Cardiovascular Events
Measured: 1, 2,3,4 and 5 years
Nuclear Factor kappa B as marker of psychosocial stress
Measured: 1,2,3,4 and 5 years
Quality of life
Measured: post intervention, 1,2,3,4 and 5 years
Psychological symptoms
Measured: post intervention, 1,2,3,4 and 5 years
Cardiovascular risk factors
Measured: post intervention, 1,2,3,4 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startJan 2005
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AlbuminuriaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Kopf MD, Heidelberg University
- Investigators
- Peter P Nawroth, MD, Principal investigator, University of Heidelberg, Dept. Medicine 1, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263419
- Sponsor's protocol ID
- HD-Med1-01/05
- Acronym
- HEIDIS
- Status last verified
- Oct 2011
- First submitted
- 7 Dec 2005
- Last updated
- 27 Oct 2011
- Results posted
- No
Publications
Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639Kopf S, Oikonomou D, Hartmann M, Feier F, Faude-Lang V, Morcos M, Haring HU, Herzog W, Bierhaus A, Humpert PM, Nawroth PP. Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS). Exp Clin Endocrinol Diabetes. 2014 Jun;122(6):341-9. doi: 10.1055/s-0034-1372583. Epub 2014 May 5.
PubMed 24798861Kopf S, Oikonomou D, von Eynatten M, Kieser M, Zdunek D, Hess G, Morcos M, Forsblom C, Bierhaus A, Groop PH, Nawroth PP, Humpert PM. Urinary excretion of high molecular weight adiponectin is an independent predictor of decline of renal function in type 2 diabetes. Acta Diabetol. 2014;51(3):479-89. doi: 10.1007/s00592-013-0542-2. Epub 2013 Dec 24.
PubMed 24366425Hartmann M, Kopf S, Kircher C, Faude-Lang V, Djuric Z, Augstein F, Friederich HC, Kieser M, Bierhaus A, Humpert PM, Herzog W, Nawroth PP. Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). Diabetes Care. 2012 May;35(5):945-7. doi: 10.2337/dc11-1343. Epub 2012 Feb 14.
PubMed 22338101
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
- ClinicalTrials.gov ID
- NCT00263419
- Acronym / sponsor ID
- HEIDIS / HD-Med1-01/05
- Keywords
- Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Dec 2005 (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.
The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.
Detailed description
Patients with type 2 diabetes and increased albumin excretion have an increased risk of renal failure and cardiovascular events. It has recently been shown, that psychosocial stress is an additional major risk factor contributing to the increased risk of cardiac events. However, it is not clear, whether a structured stress-relief training of patients reduces the risk of micro- and macrovascular damage in type 2 diabetes.
Comparisons: Conventional treatment of diabetes according to national guidelines is compared to conventional treatment plus structured stress relief management training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes Type 2
- Albuminuria
- Age 30-70
Key exclusion criteria (7 listed)
- Diabetes duration < 3 years
- Preexisting non-diabetic kidney
- Psychiatric disorders
- Alcohol or drug abuse
- Malignant tumors or hematologic disorders
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 |
|---|---|---|
| Mindfulness Based Stress ReductionAlso: Heidelberger Diabetes and Stress (HEIDIS) - Study8 weeks mindfulness based stress reduction (MBSR) based on body and meditation practices that aims at cultivation of openness, awareness of the present moment and acceptance of all internal and external experiences. It is assumed that this allows to act more reflectively rather than impulsively. | Behavioural | – |
Primary outcome
Progression of albuminuria
Time frame: 1,2,3,4 and 5 year
7 secondary outcomes
Mortality
Time frame: 3,4 and 5 years
Late diabetic complications (micro-macrovascular)
Time frame: 1,2,3,4 and 5 years
Cardiovascular Events
Time frame: 1, 2,3,4 and 5 years
Nuclear Factor kappa B as marker of psychosocial stress
Time frame: 1,2,3,4 and 5 years
Quality of life
Time frame: post intervention, 1,2,3,4 and 5 years
Psychological symptoms
Time frame: post intervention, 1,2,3,4 and 5 years
Cardiovascular risk factors
Time frame: post intervention, 1,2,3,4 and 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Derived from this study: PubMed 24798861Kopf S, Oikonomou D, Hartmann M, Feier F, Faude-Lang V, Morcos M, Haring HU, Herzog W, Bierhaus A, Humpert PM, Nawroth PP. Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS). Exp Clin Endocrinol Diabetes. 2014 Jun;122(6):341-9. doi: 10.1055/s-0034-1372583. Epub 2014 May 5.
- Derived from this study: PubMed 24366425Kopf S, Oikonomou D, von Eynatten M, Kieser M, Zdunek D, Hess G, Morcos M, Forsblom C, Bierhaus A, Groop PH, Nawroth PP, Humpert PM. Urinary excretion of high molecular weight adiponectin is an independent predictor of decline of renal function in type 2 diabetes. Acta Diabetol. 2014;51(3):479-89. doi: 10.1007/s00592-013-0542-2. Epub 2013 Dec 24.
- Derived from this study: PubMed 22338101Hartmann M, Kopf S, Kircher C, Faude-Lang V, Djuric Z, Augstein F, Friederich HC, Kieser M, Bierhaus A, Humpert PM, Herzog W, Nawroth PP. Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). Diabetes Care. 2012 May;35(5):945-7. doi: 10.2337/dc11-1343. Epub 2012 Feb 14.
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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.
Peter P Nawroth, MD principal investigator
University of Heidelberg, Dept. Medicine 1, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction in people with Albuminuria and Diabetes Mellitus, Type 2, run by Heidelberg University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 2011. 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?
Results are not available in the source record.
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?
Progression of albuminuria (time frame: 1,2,3,4 and 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263419, which also lists 4 linked publications.
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 27 Oct 2011; AzTrials last refreshed its copy on 8 Nov 2026.