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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009413
Receipt No. R000011060
Scientific Title Medium-term Effects of Passive Skeletal Muscle Motion due to Electrical Stimulation on Blood Sugar Control in Diabetic Patients
Date of disclosure of the study information 2012/11/27
Last modified on 2013/06/27

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Basic information
Public title Medium-term Effects of Passive Skeletal Muscle Motion due to Electrical Stimulation on Blood Sugar Control in Diabetic Patients
Acronym Lower limb electrical stimulation therapy in diabetic patients
Scientific Title Medium-term Effects of Passive Skeletal Muscle Motion due to Electrical Stimulation on Blood Sugar Control in Diabetic Patients
Scientific Title:Acronym Lower limb electrical stimulation therapy in diabetic patients
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to analyze and review the effects of 12 weeks of therapeutic exercise by EMS on HbA1c in type 2 diabetes patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in HbA1c
Key secondary outcomes Weight, BMI, skeletal muscle volume, somatic fat volume, knee extension muscular strength, knee extension stamina. The change in HbA1c due to preprandial and postprandial interventions, blood sugar level, insulin (IRI), C-peptide in blood (CPR), total cholesterol (T-Cho), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), neutral fat (TG), cholinesterase (ChE) (Measured while the target patients were hungry. HOMA-R and HOMA-b were calculated from fasting blood sugar level and IRI). Fatty acid compartmentation out of all lipids, glycoalbumin in blood, 1.5-AG. Blood sugar level in the glucose tolerance test, IRI, RG, CPR (area under the curve).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention groups (2 groups: preprandial intervention group and postprandial intervention group)
Electrical stimulation was conducted at >3 hours after breakfast or lunch in the preprandial intervention group, while electrical stimulation was conducted from 30 minutes to 2 hours after breakfast or lunch in the postprandial intervention group.

Electrical stimulation:
Electrodes were mounted in 6 places (the gluteus maximus muscle, quadriceps muscle, and biceps femoris muscle), from the waist to both the lower extremities. Muscular contraction was induced continuously for 30 minutes by application of 20 Hz of low-frequency electrical stimulation (electrical stimulation was conducted 3 times a week, for 12 weeks).

Interventions/Control_2 Control group:
No electrical stimulation was conducted during the 12 weeks of intervention, and only evaluation was preformed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria HbA1c (NGSP) was 7.0-9.0%, and the rate of change for the previous 16 weeks was <1%.

Both daily activities and walking were autonomous.

Age: 20 to 69 years
Key exclusion criteria Patients with diabetic complications

Proliferative retinopathy (excluding patients who were in a stable condition after photocoagulation therapy)

Stage 3B or more advanced stages of diabetic nephropathy
Patients with painful neuropathy

NYHA-2 or more advanced stages, or patients with chronic cardiac insufficiency who used pacemakers

Patients with malignant tumor and undergoing medical treatments, including chemotherapy or radiation therapy (excluding past illness)

Patients receiving adrenocortical hormone

Patients undergoing medical treatment for Cushings syndrome or acromegaly

Postgastrectomy patients

Patients with gait disturbance in the hip or knee joint (non-autonomous walking) as a motor impairment

Patients with paralysis (including incomplete paralysis) due to diseases of the central nervous system

Patients with cognitive disturbance (unable to communicate) and those unable to understand instructions





Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tsukuba University School of Hospital
Division name Department of rehabilitation
Zip code
Address 2-1-1 Amakubo, Tsukuba-shi, Ibaraki, Japan 305-8577
TEL 029-853-3795
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tsukuba University School of Hospital
Division name Department of rehabilitation
Zip code
Address 2-1-1 Amakubo, Tsukuba-shi, Ibaraki, Japan 305-8577
TEL 029-853-3795
Homepage URL
Email

Sponsor
Institute Tsukuba University School of Hospital
Institute
Department

Funding Source
Organization The Japanese Society of Physio Therapeutics
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2012 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 27 Day
Last modified on
2013 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011060

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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