NCT00960674

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

July 24, 2009

Last Update Submit

April 17, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    2008

Secondary Outcomes (1)

  • Quality of life by SF-36

    2008

Study Arms (2)

Tactile massage

EXPERIMENTAL

A gentle form of massage given once a week for three weeks

Procedure: Tactile massage

Relaxation

EXPERIMENTAL

Relaxation (by the use of a CD with relaxation exercises used at least once a week for 10 weeks)

Behavioral: Relaxation

Interventions

Tactile massagePROCEDURE

Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.

Also known as: Relaxation
Tactile massage
RelaxationBEHAVIORAL

Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks

Relaxation

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • years
  • BMI 25-30, HbA1c (Swedish standard)
  • Oral antidiabetic treatment

You may not qualify if:

  • Heart failure
  • Renal failure
  • Insufficient knowledge in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family and Community Medicin, KI

Huddinge, SE-14183, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Per E Wändell, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2009

First Posted

August 18, 2009

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

SE(1)