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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201412129626N4 |
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Date of registration:
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2015-02-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of insulin loaded nano hydrogel on blood glucose and insulin level in type 2 diabetic patients: A pilot study
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Scientific title:
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Effects of insulin loaded nano hydrogel on blood glucose and insulin level in type 2 diabetic patients: A pilot study |
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Date of first enrolment:
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2014-12-22 |
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Target sample size:
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12 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/10192 |
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Study type:
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interventional |
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Study design:
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Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Majid Mobasseri
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Address:
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Emam Reza hospital, Bone research center, Tabriz University of Medical Sciences
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3335 7850 |
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Email:
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mobasserimajid@yahoo.com |
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Affiliation:
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Bone research center, Tabriz university of medical sciences |
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Name:
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Dr. Vali Ahmadi
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Address:
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Endocrinology ward, Emam Reza Hospital, Tabriz University of Medical Sciences
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3335 7850 |
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Email:
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mobasserimajid@yahoo.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: patients with type 2 diabetes; age between 30-65 years old; HbA1c upper than 7.5 and lower than 11; drug usage included metformin + sulfonylurea; no history of conventional medical complications such as liver, kidney and cardiovascular diseases; no history of chronic uncontrolled and severe complications;
willing to participate in the study.
Exclusion criterion: lack of consent.
Exclusion criteria:
Age minimum:
30 years
Age maximum:
65 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Endocrine, nutritional and metabolic diseases
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diabetes type 2.
Endocrine, nutritional and metabolic diseases
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Intervention(s)
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Treatment - Drugs
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Insulin loaded nano hydrogel; methylenebisacrylamide + insuline regular50 miuone doseonce
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Insulin loaded nano hydrogel; methylenebisacrylamide + insuline regular50 miuone doseonce.
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Primary Outcome(s)
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Blood glucose. Timepoint: In the time of 15 min, zero hour, 1.5 hours, 3 hours, 4.5 hours, 6 hours, 12 hours and 24 hours after insulin loaded nano hydro gel. Method of measurement: Colometric method.
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Insulin level. Timepoint: In the time of 15 min, zero hour, 1.5 hours, 3 hours, 4.5 hours, 6 hours, 12 hours and 24 hours after insulin loaded nano hydro gel. Method of measurement: Chemoluminescence method.
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Source(s) of Monetary Support
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Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Researech vice-Chancellor
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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