The effect of CoQ10 supplementation on neuropathic symptoms, blood glucose and some inflammatory and antioxidant parameters in patients with type 2 diabetes
In this double blind randomized controlled trial, we investigate the effects of coenzyme Q10 on neuropathic symptoms, blood Glucose, insulin, hsCRP, and TAC (Total antioxidant capacity) in type two diabetes. In this study 70 diabetic patients with neuropathic symptoms which have been recognized by using the Michigan Questionnaire and examination of nerve reflexes will be recruited from Yazd Diabetes Research Center. The patients will be randomly divided into two groups to receive daily either 200 mg CoQ10 (divided dose) or placebo (edible microcrystal cellulose) for 12 weeks. NCS (Nerve Conduction Study ) will be assessed by using The Electromyography Method at onset and at the end of the study. For biochemical analysis 8ml of blood will be collected at the beginning and at the end of the trial. During the intervention period, individuals consume their usual diet and medicine. After collecting the data, they will be coded and analyzed in the SPSS program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109127541N1
Registration date:2011-10-27, 1390/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Maryam Akbari
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 34 5423 2517
Email address
maryamakbari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-19, 1391/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of CoQ10 supplementation on neuropathic symptoms, blood glucose and some inflammatory and antioxidant parameters in patients with type 2 diabetes
Public title
The effect of CoQ10 supplementation on some complications of type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1.The agreement of the patients to contribute in the trial; 2. patients that have type two diabetes for at least 5 years; 3.The patients should have neuropathy symptoms that have been recognized by a physician (The patients’ score on the Michigan score should be at least 8 and their nerve reflexes should be weak); 4.The patients should not have any other neurologic, kidney or hepatic diseases; 5.If the patients take medicine for neuropathy, the dosage of their medicine should not change during the trial; 6.If the patients have not taken a medicine at the beginning of the trial, they should not start taking it during the trial; 7.The patients should not have taken antioxidant supplements from the past 3 months. Exclusion criteria 1.If a dosage of a patient's medicine changes that patient will be excluded from the trial; 2.If a patient who has not taken any medicine for his neuropathy starts to take a medicine during the trial that patient will be excluded from the trial; 3.Pregnancy and lactation.
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences and Health Services
Street address
Daneshju Blvd, Imam Hossein sq
City
Yazd
Postal code
Approval date
2011-03-16, 1389/12/25
Ethics committee reference number
17/1/39322/پ
Health conditions studied
1
Description of health condition studied
Type II Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Michigan score
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Michigan neuropathy screening instrument
2
Description
hs-CRP
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Elisa
3
Description
TAC (Total antioxidant capacity)
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Elisa
4
Description
FBS (fasting blood glucose)
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
glucose oxidase method
5
Description
Fasting Insulin
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Elisa
6
Description
Insulin Resistance
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Homeostasis Model Assessment of Insulin Resistance, HOMA-IR
7
Description
sensitivity to insulin
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
HOMA Calculator for excel ver 2.2 (diabetes trials unit university of oxford)
8
Description
the secretion function of the Pancreas’s β cells
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
HOMA Calculator for excel ver 2.2 (diabetes trials unit university of oxford)
Secondary outcomes
1
Description
NCS (Nerve conduction study)
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Electromyography device
Intervention groups
1
Description
The intervention group will take 100 mg CoQ10 capsules twice a day for 3 months
Category
Treatment - Drugs
2
Description
The control group will take 100 mg placebo (edible microcrystalin celulose) capsules twice a day for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Daneshju Blvd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Maryam Akbari
Position
student
Other areas of specialty/work
Street address
Behdasht Faculty, Daneshju Blvd
City
Yazd
Postal code
Phone
+98 35 1724 9333
Fax
Email
maryamakbari_f@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr. Azadeh Nadjarzadeh
Position
PHD of Nutrition and Diet Therapy
Other areas of specialty/work
Street address
Behdasht Faculty, Daneshju Blvd
City
Yazd
Postal code
Phone
+98 35 1724 9333
Fax
Email
azadehnajarzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services of Yazd
Full name of responsible person
Maryam Akbari
Position
student
Other areas of specialty/work
Street address
Daneshju Blvd
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)