Protocol summary
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Study aim
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To determine the supplementation effect of taurine on serum levels of adiponectin, irisin, fibroblast growth factor-21, sirtuin-1, metabolic parameters, oxidative, inflammatory indicators and nutritional status in patients with type 2 diabetes
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Design
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Randomized double-blind clinical trial with two arm parallel groups phase 3 trial
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Settings and conduct
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The trial will be conducted at outpatient cardiology clinic of Imam Reza center affiliated to Tabriz University of Medical Sciences, Iran. All the patients will be screened by an expert endocrinologist for eligibility. Those willing to take part in the study will be carefully evaluated with reference to inclusion criteria. Then, they will be requested to sign an informed consent. A third party who is blind to the study will give the sequence extracted from allocation software. After an overnight fasting, blood will be collected and supplements will be provided to the participants. supplementation duration will be 8 weeks.
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Participants/Inclusion and exclusion criteria
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46 patients with type 2 diabetes are included in the study. Patients with cardiovascular, renal, hepatic, hypothyroidism, and hyperthyroidism and those who have received supplementary foods in the last 3 months will not be included in the study.
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Intervention groups
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Intervention group: will consume 3 milliliters of Turin capsules daily. (placebo) control group: Take 3 capsules containing maltodextrin daily.
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Main outcome variables
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Serum levels of adiponectin, irisin, fibroblast growth factor-21, sirtuin-1, metabolic parameters, oxidative, inflammatory indicators and nutritional status
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121028011288N16
Registration date:
2019-02-08, 1397/11/19
Registration timing:
registered_while_recruiting
Last update:
2019-04-15, 1398/01/26
Update count:
1
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Registration date
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2019-02-08, 1397/11/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-21, 1397/11/01
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Expected recruitment end date
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2019-04-22, 1398/02/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of taurine supplementation on serum levels of adiponectin, irisin, fibroblast growth factor-21, sirtuin-1, metabolic parameters, oxidative, inflammatory indicators and nutritional status in patients with type 2 diabetes
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Public title
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Taurine in type 2 diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Type 2 Diabetes
Patients who use glucose lowering oral medications are well controlled by their blood glucose levels.
Body mass index 35-25 kg /m 2 will be included in the study.
age range from 30-60 years
Exclusion criteria:
Use of multi-vitamin and mineral supplements over the past 3 months.
Taking corticosteroids and non-steroidal anti-inflammatory drugs.
Taking insulin
Patients with polycystic ovary syndrome
Patients with chronic diseases such as cardiovascular, renal and hepatic disorders, and hypothyroidism and hyperthyroidism
Having certain physiological conditions such as pregnancy and lactation.
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The eligible participants will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the taurine capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company (karenCompany).
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-19, 1397/08/28
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Ethics committee reference number
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IR.TBZMED.REC.1397.682
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Level of adiponectin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of adiponectin via ELISA kit
2
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Description
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Level of irisin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of irisin via ELISA kit
3
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Description
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Level of fibroblast growth factor-21 (FGF-21)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of fibroblast growth factor-21 (FGF-21) via ELISA kit
4
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Description
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Level of sirtuin-1
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of sirtuin-1 via ELISA kit
5
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Description
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Level of fasting blood sugar (FBS)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of fasting blood sugar (FBS) by enzymatic method
6
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Description
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Level of insulin
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of insulin by enzymatic method
7
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Description
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Level of hemoglobin A1C
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of hemoglobin A1C by enzymatic method
8
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Description
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HOMA-IR scores
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of HOMA-IR score using formula.
9
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Description
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Serum level of total cholesterol (TC)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total cholesterol (TC) level via enzymatic kit
10
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Description
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Serum level of triglyceride
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of triglyceride (TG) level via enzymatic kit
11
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Description
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Serum level of HDL
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of HDL level via enzymatic kit
12
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Description
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Serum level of LDL
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of LDL using friedewald equation
13
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Description
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Serum level of total antioxidant capacity (TAC)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total antioxidant capacity (TAC) by spectrophotometry
14
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Description
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Serum level of malondialdehyde (MDA)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of malondialdehyde (MDA) by spectrophotometry
15
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Description
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Serum level of catalase
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of catalase by spectrophotometry
16
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Description
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Serum level of superoxide dismutase (SOD)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of superoxide dismutase (SOD) by spectrophotometry
17
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Description
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Serum level of TNF-a
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of TNF-a via ELISA kit
18
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Description
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Serum level of interleukin-6 (IL-6)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of interleukin-6 (IL-6) via ELISA kit
19
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Description
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Serum level of hs-CRP
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of hs-CRP via ELISA kit
Secondary outcomes
1
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Description
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Assessment of the body composition
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Timepoint
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At the beginning of the study and 8 weeks later
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Method of measurement
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Assess body composition using the body composition analyzer
2
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Description
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Physical activity level
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Via IPAQ questionnaire
3
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Description
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Assessment of dietary intake
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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3-day food record
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive 3 capsules of 1000 milligrams of taurine (product by karen Co. and made in The Iran) for 8 weeks a day.
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Category
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Treatment - Drugs
2
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Description
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Control group: Control group: Patients in this group will receive maltodextrin capsules for 8 weeks which are same size and shape ( product by karen Co. and made in The Iran) and used once a day with lunch.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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Accessibility to data is possible 8 months after publication.
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta analysis.
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From where data/document is obtainable
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Dr. Mohammad Alizadeh, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
Email: mdalizadeh@tbzmed.ac.ir
0098 9141894102
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What processes are involved for a request to access data/document
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The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person.
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Comments
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