Osteoarthritis is the commonest chronic disease affected the joints in aging. Short intravenous consumption of glucosamine dose not effective on insulin sensitivity. The aim of present study is to evaluate glucosamine effect on blood sugar, insulin and insulin resistance of osteoarthritis patients and comparison of these factors in placebo group. The voluntary osteoarthritis non diabetic patients who randomly divided into two control and intervention groups with 20 cases are received 1500 mg glucosamine capsules daily till three months and placebo capsules. Fast blood glucose, glucose tolerance test and insulin level are measured from the baseline and after 3 months intervention. Results are analyzed as the changes in fast blood glucose, glucose tolerance test, insulin level and insulin resistance level in both intervention and control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304284167N5
Registration date:2014-05-08, 1393/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Shokoufeh Bonakdaran
Name of organization / entity
Endocrine Research Center
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2976
Email address
bonakdaransh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oral Glucosamine on blood glucose and insulin level in patients with osteoarthritis during glucose tolerance test
Public title
Effect of Oral Glucosamine on glucose and insulin levels in patients with osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Osteoarthritis non diabetic patients with American College Of Rheumatology criteria for diagnosis of osteoarthritis of hand, knee and or hip; patients who complete the consent form and participate to study consciously.
Exclusion criteria: Having body mass index lower than 20 and or higher than 30, history of diabetes or fast blood sugar upper than 110; history of liver or renal disease, myocardial infarction, uncontrolled inflammatory diseases, malignancy and endocrine disorder which interfere glucose metabolism; consumption of corticosteroids and other effective medicine on blood glucose; anemia; pregnancy or lactation
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2008-09-22, 1387/07/01
Ethics committee reference number
87920
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyarthrosis, unspecified
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Baseline and after 3 months intervention
Method of measurement
Glucose oxidase Method
2
Description
Glucose tolerance test
Timepoint
Baseline and after 3 months intervention
Method of measurement
Glucose oxidase Method
3
Description
Fasting insulin serum
Timepoint
Baseline and after 3 months intervention
Method of measurement
Immunoradiometric assay
Secondary outcomes
1
Description
Insulin Resistance
Timepoint
Baseline and after 3 months intervention
Method of measurement
HOMA-IR index
2
Description
Fasting insulin serum
Timepoint
Baseline and after 3 months intervention
Method of measurement
Immunoradiometric assay
3
Description
Fasting blood glucose
Timepoint
Baseline and after 3 months intervention
Method of measurement
Glucose oxidase Method
4
Description
Glucose tolerance test
Timepoint
Baseline and after 3 months intervention
Method of measurement
Glucose oxidase Method
Intervention groups
1
Description
Intervention group: Glucosamine 1500 mg daily until three months
Category
Treatment - Drugs
2
Description
Control group: One placebo tablet daily till 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Shokoufeh Bonakdaran
Position
Associate Professor
Other areas of specialty/work
Street address
Endocrine Research Center, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2976
Fax
Email
bonakdaransh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Shokoufeh Bonakdaran
Position
Associate professor
Other areas of specialty/work
Street address
Endocrine Research Center, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2976
Fax
Email
bonakdaransh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Shokoufeh Bonakdaran
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)