UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009413 |
|---|---|
| Receipt number | 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 15:40:21 |
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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
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
Sponsor or person
Institute
Tsukuba University School of Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011060
