1. Home
  2. Approved trials
  3. » فارسی

The effect of glucosamine supplementation on fasting blood glucose, fasting insulin, glycosylated hemoglobin and insulin resistance in type 2 diabetic patients: a randomized, double-blind and placebo-controlled trial

Protocol summary

Summary
The aim of this study was to determine the effect of glucosamine supplementation on fasting blood glucose level, fasting insulin, glycosylated hemoglobin and insulin resistance in type 2 diabetic patients. In this randomized, double-blind and placebo-controlled clinical trial, a total number of 58 type 2 diabetic patients were selected from Shiraz health care centers. They were randomly divided into intervention and control groups. The intervention group received 1500 mg glucosamine hydrochloride supplements once a day, while the control group received placebo capsules. They were intervened for twelve weeks. Blood samples were collected from the fasted participants at weeks of 0, 4, 8 and 12. Fasting blood glucose levels were measured at weeks of 0, 4, 8 and 12, while glycosylated hemoglobin, insulin and markers of insulin resistance (HOMA and QUICKI indices) were assessed in the weeks of 0, 8 and 12.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031811785N2
Registration date: 2014-04-05, 1393/01/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-05, 1393/01/16
Registrant information
Name
Mahsa Moazen
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
moazzen@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2006-06-22, 1385/04/01
Expected recruitment end date
2006-11-22, 1385/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of glucosamine supplementation on fasting blood glucose, fasting insulin, glycosylated hemoglobin and insulin resistance in type 2 diabetic patients: a randomized, double-blind and placebo-controlled trial
Public title
Effect of glucosamine consumption on blood glucose and insulin levels in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirmed diagnosis of type 2 diabetes; fasting blood sugar <150 mg/dl; glycosylated hemoglobin <7%; management of diabetes with a stable dose of hypoglycemic drugs. Exclusion criteria: Insulin therapy; having shellfish allergy; use of any medications which alter glucose control; having history of cardiovascular diseases and thyroid disorders
Age
From 40 years old to 79 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 58
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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2006-06-07, 1385/03/17
Ethics committee reference number
CT-85-2813

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting blood glucose
Timepoint
Weeks of 0, 4, 8 and 12
Method of measurement
Auto Analyzer, unit: mg/dl

2

Description
Fasting insulin
Timepoint
Weeks of 0, 8 and 12
Method of measurement
ELISA method, unit: μu/ml

3

Description
Glycosylated hemoglobin
Timepoint
Weeks of 0, 8 and 12
Method of measurement
Ion exchange chromatography, unit: percent

4

Description
HOMA index
Timepoint
Weeks of 0, 8 and 12
Method of measurement
According to formula

5

Description
QUICKI index
Timepoint
Weeks of 0, 8 and 12
Method of measurement
According to formula

Secondary outcomes

1

Description
Body mass index
Timepoint
Weeks of 0 and 12
Method of measurement
According to formula, unit: Kg/m2

Intervention groups

1

Description
Placebo capsules containing calcium phosphate, once a day, for twelve weeks, edible, made in Shiraz School of Pharmacy
Category
Placebo

2

Description
Glucosamine hydrochloride supplement, 1500 mg, once a day, for 12 weeks, edible, Vitamin World Company of USA
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Naderkazemi medical center
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Motahari medical center
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmodini
Street address
Central Building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Nutrition and Food Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Associate professor
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nutrition and Food Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Associate professor
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutrition and Food Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Associate professor
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...