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

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 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


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

Value
https://center6.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