Clinical trial NCT00263419: Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
Official title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Albuminuria
Diabetes Mellitus, Type 2
Diabetes Complications
Keywords: Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Progression of albuminuria
timeFrame: 1,2,3,4 and 5 year
Secondary outcomes:
measure: Mortality
timeFrame: 3,4 and 5 years
measure: Late diabetic complications (micro-macrovascular)
timeFrame: 1,2,3,4 and 5 years
measure: Cardiovascular Events
timeFrame: 1, 2,3,4 and 5 years
measure: Nuclear Factor kappa B as marker of psychosocial stress
timeFrame: 1,2,3,4 and 5 years
measure: Quality of life
timeFrame: post intervention, 1,2,3,4 and 5 years
measure: Psychological symptoms
timeFrame: post intervention, 1,2,3,4 and 5 years
measure: Cardiovascular risk factors
timeFrame: post intervention, 1,2,3,4 and 4 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Medicine, University of Heidelberg
Study officials:
affiliation: University of Heidelberg, Dept. Medicine 1, Germany
name: Peter P Nawroth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopf 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.
citation: Kopf 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.
citation: Hartmann 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.