Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
53 participants
INTERVENTIONAL
2007-08-31
2008-12-31
Brief Summary
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The study aimed at comparing the effect of tactile massage sessions for one hour given once a week for 10 weeks in comparison with relaxation through a relaxation CD performed once a week during 10 weeks. Primary outcome was HbA1c measured after completed intervention and after yet another 12 weeks. Secondary outcomes were quality of life by SF-36, other markers of metabolism (fasting glucose, insulin resistance by HOMA-model), inflammation (CRP, cytokines) and stress (cortisone, catecholamines).
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Detailed Description
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The present study aimed at studying the effects in a randomized controlled study, with patients provided with a relaxation cd available at pharmacies in Sweden. Power calculations found that 20-25 subjects in each group would be sufficient to show effect on HbA1c (0.8% vs 0.3%), but that 45-50 subjects would be needed to show clinical relevant effect on quality of life.
Patients aged 35-75 years with type 2 diabetes and BMI 25-30 and HbA1c 6-8%-units (Swedish standard, corresponding to 7-9%-units in DCCT standard) from primary health care centres in Stockholm County were invited to participate, and was randomly assigned to tactile massage or relaxation groups.
Exclusion criteria was heart or renal failure, treatment with insulin, problems with Swedish language. Besides, only subjects of Swedish ethnicity were included in this first study, in order to refine results and avoid confusional results.
Examination with laboratory tests, body examination and questionnaire, including SF-36 and questions on smoking, dietary and physical activity habits, was performed before intervention, after the 10 weeks examination and after yet another 12 weeks. Urine sampling on catecholamines and corticosteroids was performed, and blood tests on HbA1c, fasting glucose, insulin, CRP, cytokines (TNF-alpha, IL-6), adiponectin, leptin, ghrelin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tactile massage
A gentle form of massage given once a week for three weeks
Tactile massage
Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.
Relaxation
Relaxation (by the use of a CD with relaxation exercises used at least once a week for 10 weeks)
Relaxation
Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
Interventions
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Tactile massage
Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.
Relaxation
Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 35-75 years
* BMI 25-30, HbA1c (Swedish standard)
* Oral antidiabetic treatment
Exclusion Criteria
* Renal failure
* Insufficient knowledge in Swedish
35 Years
75 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Per Wandell
Professor
Principal Investigators
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Per E Wändell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Center for Family and Community Medicin, KI
Huddinge, , Sweden
Countries
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Other Identifiers
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2007/414-31/4
Identifier Type: -
Identifier Source: org_study_id
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