Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes (HEIDIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Heidelberg University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Stefan Kopf MD, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00263419
First received: December 7, 2005
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Albuminuria
Diabetes Mellitus, Type 2
Diabetes Complications
Behavioral: Mindfulness Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Progression of albuminuria [ Time Frame: 1,2,3,4 and 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 3,4 and 5 years ] [ Designated as safety issue: No ]
  • Late diabetic complications (micro-macrovascular) [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
  • Cardiovascular Events [ Time Frame: 1, 2,3,4 and 5 years ] [ Designated as safety issue: No ]
  • Nuclear Factor kappa B as marker of psychosocial stress [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: post intervention, 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
  • Psychological symptoms [ Time Frame: post intervention, 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Time Frame: post intervention, 1,2,3,4 and 4 years ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2005
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness Based Stress Reduction
    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.
    Other Name: Heidelberger Diabetes and Stress (HEIDIS) - Study
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Type 2
  • Albuminuria
  • Age 30-70

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263419

Locations
Germany
Department of Medicine, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Peter P Nawroth, MD University of Heidelberg, Dept. Medicine 1, Germany
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Kopf MD, Prof. P.P. Nawroth & Dr. med S. Kopf, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00263419     History of Changes
Other Study ID Numbers: HD-Med1-01/05
Study First Received: December 7, 2005
Last Updated: October 26, 2011
Health Authority: Germany: Regierungspräsidium Karlsruhe

Keywords provided by Heidelberg University:
Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress

Additional relevant MeSH terms:
Albuminuria
Diabetes Complications
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014