Type 2 DiabetesPhase 3NCT00960674
Tactile Massage in Type 2 Diabetes
A Phase 3 study testing Tactile massage and Relaxation in people with Type 2 Diabetes, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Tactile massage is a gentle form of massage that probably exerts its effect through relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen. 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tactile massage and Relaxation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- 35-75 years
- BMI 25-30, HbA1c (Swedish standard)
- Oral antidiabetic treatment
Who cannot join
- Heart failure
- Renal failure
- Insufficient knowledge in Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Type 2 Diabetes by Tactile Massage Compared to Relaxation With Relaxation Tape
Tactile massage is a gentle form of massage that probably exerts its effect through relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.
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).
Read the detailed description
Effects of different relaxation techniques on metabolic control in type 2 diabetes have been described. A pilot study indicated an effect by tactile massage, a Swedish form of gentle massage given in sessions of around one hours and including treatment of the whole body in general, on metabolic control measured as HbA1c and on plasma corticosteroids.
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
- Type 2 Diabetes
- Being tested
- Tactile massage, Relaxation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile massageProcedure or surgery
Also called Relaxation
Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.
RelaxationBehavioural
Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
| Study group | Role | What they receive |
|---|---|---|
| Tactile massage | Experimental | A gentle form of massage given once a week for three weeks Receives: Procedure: Tactile massage |
| Relaxation | Experimental | Relaxation (by the use of a CD with relaxation exercises used at least once a week for 10 weeks) Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 2008
Secondary outcomes (1)
Quality of life by SF-36
Measured: 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Per Wandell, Karolinska Institutet
- Investigators
- Per E Wändell, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960674
- Sponsor's protocol ID
- 2007/414-31/4
- Status last verified
- Apr 2013
- First submitted
- 24 Jul 2009
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Type 2 Diabetes by Tactile Massage Compared to Relaxation With Relaxation Tape
- ClinicalTrials.gov ID
- NCT00960674
- Acronym / sponsor ID
- 2007/414-31/4
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Aug 2009 (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.
Tactile massage is a gentle form of massage that probably exerts its effect through relaxation. In a pilot study of 11 subjects an effect on HbA1c of 0.8%-units was seen.
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).
Detailed description
Effects of different relaxation techniques on metabolic control in type 2 diabetes have been described. A pilot study indicated an effect by tactile massage, a Swedish form of gentle massage given in sessions of around one hours and including treatment of the whole body in general, on metabolic control measured as HbA1c and on plasma corticosteroids.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tactile massage | Experimental | Procedure: Tactile massageA gentle form of massage given once a week for three weeks |
| Relaxation | Experimental | Behavioral: RelaxationRelaxation (by the use of a CD with relaxation exercises used at least once a week for 10 weeks) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- 35-75 years
- BMI 25-30, HbA1c (Swedish standard)
- Oral antidiabetic treatment
Key exclusion criteria (3 listed)
- Heart failure
- Renal failure
- Insufficient knowledge in Swedish
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 |
|---|---|---|
| Tactile massageAlso: RelaxationGentle massage given for one hour by specially educated massage therapists, usually registered nurses. | Procedure or surgery | Tactile massage |
| RelaxationRelaxation by a CD with relaxation exercises, at least one hour per week for ten weeks | Behavioural | Relaxation |
Primary outcome
HbA1c
Time frame: 2008
1 secondary outcome
Quality of life by SF-36
Time frame: 2008
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 18 Apr 2013.
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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.
Per E Wändell, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tactile massage and Relaxation in people with Type 2 Diabetes, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 3 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 18 Apr 2013. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HbA1c (time frame: 2008). 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 18 Apr 2013.