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Effect of powdered sumac (Rhus coriaria L) on glycemic control and insulin resistance in patients with type 2 diabetes.

Protocol summary

Summary
The purpose of this study was to investigate the effect of sumac powder on the status of blood glucose 2 hours after a meal, hemoglobin A1C, insulin resistance, serum homocysteine, and HS-CRP in type II diabetic patients. In this randomized, controlled clinical trial, 60 patients with Type II diabetes and eligible applicants are selected for the study. Patients about to get crushed powder 6 g daily for 3 months. After the 3-month intervention period, fasting and 2-hour postprandial serum glucose, hemoglobin A1C, insulin resistance, beta-cell function, serum Homocysteine, and HS-CRP between the two groups will be compared levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050410826N9
Registration date: 2014-06-14, 1393/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Yazd University of Medical Sciences
Expected recruitment start date
2014-05-17, 1393/02/27
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of powdered sumac (Rhus coriaria L) on glycemic control and insulin resistance in patients with type 2 diabetes.
Public title
Effect of sumac powder on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: individuals between 30 and 60 years of their diabetes diagnosed diabetes center and at least 3 years of getting passed; lack of disorders and diseases of the liver and biliary and renal disorders; no professional athletes; not taking antioxidant supplements, selenium, zinc, beta carotene, omega-3 and at least 3 months before the study began; no alcohol; the willingness of patients to participate in the study; refusing to participate in other research projects; no change in dose or type of medication; do not use insulin. Exclusion criteria: those who consume less than 80 percent were crushed packages; people who have changed the type and dose of your medication; the patient's unwillingness to continue the study; start taking any antioxidant supplement; recent receiving insulin; to become pregnant during the study; diseases of liver and biliary and renal dysfunction during the study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the Medical University of Yazd
Street address
Yazd University of Medical Sciences, Daneshjoo blv.
City
Yazd
Postal code
8916189165
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
17/1/171485/پ

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
Glucose oxidase method

2

Description
Glycosylated hemoglobin
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
Spectrophotometric

3

Description
Insulin
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
IRMA

4

Description
Insulin Resistance
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
(glucose × insulin)/22.5

5

Description
Blood sugar levels two hours after a meal
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
Glucose oxidase method

6

Description
Beta-cell function
Timepoint
Before the intervention and after the intervention (3 months later)
Method of measurement
The amount of beta-cell function=(Fasting insulin × 20) / (fasting glucose, -3.5)

Secondary outcomes

1

Description
Added at 2016-11-29: HS-CRP
Timepoint
Added at 2016-11-29: At the beginning and the end of study period
Method of measurement
Added at 2016-11-29: 10 ml blood sample

Intervention groups

1

Description
Control group:take 2 cup low-fat yogurt daily without sumac for 3 months with lunch and dinner
Category
Placebo

2

Description
Intervention group: Daily for 3 months, 6 grams of powdered sumac two servings (1 sachet 3 grams with lunch and one sachet 3 grams with dinner) was mixed with low-fat yogurt are used.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardakan Diabetes Center(Clinic Mehr)
Full name of responsible person
Mohammad Reza Fatahi Ardakani
Street address
Alley Civil Registration office, Beheshti Boulevard
City
Ardakan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ezzedini Ardekani
Street address
Maxillofacial Radiology, Faculty of Dentistry, Imam Street
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Position
Nutrition PhD, Assistant Professor
Other areas of specialty/work
Street address
Nutrition Department- Faculty of Health-Imam Reza Educational Research Center-Student Boulevard
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
azadnajarzadeh@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Position
Nutrition PhD
Other areas of specialty/work
Street address
Nutrition Department- Faculty of Health-Imam Reza Educational Research Center-Student Boulevard
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
azadnajarzadeh@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Reza Fattahi Ardekani
Position
Graduate student in Nutrition and Health Sciences
Other areas of specialty/work
Street address
No. 52, Alley No. 97, Hafez Street.
City
Ardakan
Postal code
Phone
+98 35 2722 6742
Fax
Email
mrfa67@yahoo.com
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
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