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Effects of probiotics on lipid profile, glycemic index, oxidative stress and inflammatory markers in patients with diabetes type 2; a clinical trial study

Protocol summary

Summary
Objective: the effect of probiotics on the biochemical parameters as markers of cardiovascular disease in patients with type 2 diabetes. Inclusion and Exclusion Criteria: Patients with diabetes type 2 are enrolled with FBS≥126 mgr/dl and less than 15 years of medical history and the age range was 25 to 65 years. Elective subjects should not use alternative treatments like Hormone therapy or supplemental vitamin. Also those patients with chronic kidney disease, liver, lung and chronic or acute inflammatory disease, heart valve disease, short bowel syndrome and allergies and also, people with low immune system ability (autoimmune) and pregnant or lactating women, were removed. Population and sample size: Forty patients with type 2 diabetes among people eligible to participate and referred to PERSIAN GULF HOSPITAL, was selected. Intervention: These patients were divided to either an intervention (receiving probiotic capsule) or placebo (receiving placebo) groups. After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After six weeks, fasting blood samples were tested again. The beginning and end of the study: 6 weeks (SEPTEMBER 6, 2010 - NOVEMBER 6, 2010) Outcomes: Baseline serum LDL-C, HDL-C, TG and total cholesterol, glucose, insulin, malondialdehyde, hs-CRP and IL-6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071127879N2
Registration date: 2016-09-22, 1395/07/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Abbas Yousefinejad
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0178
Email address
a.yousefinezhad@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotics on lipid profile, glycemic index, oxidative stress and inflammatory markers in patients with diabetes type 2; a clinical trial study
Public title
Effects of probiotics on lipid profile, glycemic index, oxidative stress and inflammatory markers in patients with diabetes type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetes type 2 are enrolled with FBS≥126 mgr/dl; less than 15 years of medical history; the age range is 25 to 65 years; the elective subjects, next drugs prescribed by physicians, should be controlled the status of glucose and lipid levels and during the study could use these drugs without changing in the prior dosage. Exclusion Criteria: Patients with diabetes type 2 that used alternative treatments like hormone therapy or supplemental vitamins; also those used tobacco and alcohol; patients with chronic kidney disease; liver, lung, chronic or acute inflammatory disease (especially acute pancreatic inflammation and Endocarditis); heart valve disease; short bowel syndrome; allergies; people with low immune system ability (autoimmune); pregnant or lactating women.
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.BPUMS.REC.1395.64

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
Lipid Profile (Tg,Total Chol, LDL-C, HDL-C)
Timepoint
Before and After Intervention
Method of measurement
Autoanalyzer

2

Description
Serum Glucose
Timepoint
Before and after Intervention
Method of measurement
Autoanalyzer

3

Description
Serum Insulin Levels
Timepoint
Before and After Intervention
Method of measurement
ELISA

4

Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
ELISA

5

Description
IL-6
Timepoint
Before and After Intervention
Method of measurement
Autoanalyzer

6

Description
Malodialdehyde (MDA)
Timepoint
Before and after Intervention
Method of measurement
Specterophotometery

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: patients in the treatment group received 1500 mg probiotic capsules twice daily (after lunch and dinner meals) for 6 weeks. The lactobacillus Probiotics contain: L. acidophilus 3.6 billion (×109 CFU) L. bulgaricus 600 million (×106 CFU) L. bifidum 600 million (×106 CFU) L. casei 1.2 billion (×109 CFU)
Category
Treatment - Drugs

2

Description
Control: Placebo Group receiving 1500 mg Magnesium Stearate capsules twice daily, for six weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
PERSIAN GULF HOSPITAL of BUSHEHR
Full name of responsible person
Hanieh Nozari
Street address
City
BUSHEHR

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Samira Zare
Street address
Research Deputy of Bushehr University of Medical Sciences, Bahmani St, Bushehr, Iran
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Abbas Yousefinejad
Position
PhD/Assisstant Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Bahmani St, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3345 0134
Fax
Email
yousefinejad.abs@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical sciences
Full name of responsible person
Abbas Yousefinejad
Position
PhD
Other areas of specialty/work
Street address
Bushehr University of Medical sciences, Bahmani St, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3345 0134
Fax
Email
yousefinejad.abs@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abbas Yousefinejad
Position
PhD
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Bahmani St, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3345 0134
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
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