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出境医 / 临床实验 / Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Study Description
Brief Summary:
The aim of the study is to assess the effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Device: Rotating Magnetic Therapy Drug: Mecobalamin Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Sham Comparator: Control group
Mecobalamine 0.5mg, tid
 Drug: Mecobalamin
mecobalamine 0.5mg,tid
Experimental: Rotating Magnetic Therapy
Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
 Device: Rotating Magnetic Therapy
Rotating Magnetic Therapy 30min, bid

Drug: Mecobalamin
mecobalamine 0.5mg,tid
Outcome Measures
Primary Outcome Measures :
  1. Nerve conduction velocity examination [ Time Frame: 1 month ]
    the change of Nerve conduction velocity examination


Secondary Outcome Measures :
  1. MNSI [ Time Frame: 1 month ]
    Michigan Neuropathy Screening Instrument

  2. Glycosylated serum albumin [ Time Frame: 1 month ]
    the change of Glycosylated serum albumin


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 1. Volunteer to participate and sign informed consent prior to the study 2. Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy).

3. HbA1c<7.5%, the hypoglycemic regimen was stable for 3 months 4. No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.

Exclusion Criteria:

  • 1. Patients with foreign metal bodies or pacemakers 2. Patients with a history of surgery at magnetic therapy sites within one year 3. Patients with obvious discomfort to magnetic therapy 4. Patients with bleeding or bleeding tendency 5. Patients with acute complications such as diabetic ketoacidosis 6. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal 7. History of drug abuse and alcohol dependence in the past 5 years 8. Systemic hormone therapy was used in the last three months 9. Patients with infection and stress within 4 weeks 10. Patients who are pregnant, breast-feeding, or intending to become pregnant. 11. Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 17, 2019
Estimated Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		Nerve conduction velocity examination [ Time Frame: 1 month ]
the change of Nerve conduction velocity examination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • MNSI [ Time Frame: 1 month ]
    Michigan Neuropathy Screening Instrument
  • Glycosylated serum albumin [ Time Frame: 1 month ]
    the change of Glycosylated serum albumin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Official Title  ICMJE Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Brief Summary The aim of the study is to assess the effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • Device: Rotating Magnetic Therapy
    Rotating Magnetic Therapy 30min, bid
  • Drug: Mecobalamin
    mecobalamine 0.5mg,tid
Study Arms  ICMJE
  • Sham Comparator: Control group
    Mecobalamine 0.5mg, tid
    Intervention: Drug: Mecobalamin
  • Experimental: Rotating Magnetic Therapy
    Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
    Interventions:
    • Device: Rotating Magnetic Therapy
    • Drug: Mecobalamin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- 1. Volunteer to participate and sign informed consent prior to the study 2. Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy).

3. HbA1c<7.5%, the hypoglycemic regimen was stable for 3 months 4. No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.

Exclusion Criteria:

  • 1. Patients with foreign metal bodies or pacemakers 2. Patients with a history of surgery at magnetic therapy sites within one year 3. Patients with obvious discomfort to magnetic therapy 4. Patients with bleeding or bleeding tendency 5. Patients with acute complications such as diabetic ketoacidosis 6. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal 7. History of drug abuse and alcohol dependence in the past 5 years 8. Systemic hormone therapy was used in the last three months 9. Patients with infection and stress within 4 weeks 10. Patients who are pregnant, breast-feeding, or intending to become pregnant. 11. Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983200
Other Study ID Numbers  ICMJE KY20190530-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Majianhua, Nanjing First Hospital, Nanjing Medical University
Study Sponsor  ICMJE Majianhua
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanjing First Hospital, Nanjing Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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