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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201410000894447 |
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Date of registration:
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28/09/2014 |
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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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Efficacy and cost of Stevia rebaudiana Bertoni extract as adjunctive therapy in Sahrawi patients with Type 2 diabetes
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Scientific title:
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Efficacy of Stevia rebaudiana Bertoni extract as adjunctive therapy in Sahraoui patients with Type 2 diabetes. A Randomized, Controlled, Cross-over, Double-Blind Trial |
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Date of first enrolment:
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01/01/2013 |
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Target sample size:
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79 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=894 |
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Study type:
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Interventional |
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Study design:
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Crossover: all participants receive all interventions in different sequence during study,Randomised,random number electronic table,sealed opaque envelope
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Phase:
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Not Applicable
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Countries of recruitment
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Morocco
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Contacts
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Name:
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Genís
Carrasco |
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Address:
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Provenza 159
08034
Barcelona
Spain |
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Telephone:
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0034626550055 |
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Email:
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geniscarrasco@telefonica.net |
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Affiliation:
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Clinical chief, statistics and communication |
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Name:
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Genís
Carrasco |
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Address:
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Provenza 159
08036
B
Spain |
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Telephone:
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0034626550055 |
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Email:
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geniscarrasco@telefonica.net |
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Affiliation:
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Clinical chief and statistics |
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Key inclusion & exclusion criteria
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Inclusion criteria: inclusion criteria: (1) Type 2 diabetes treated with diet and/or oral agents; (2) development of diabetes in an age greater than 30 years; (3) diabetes duration greater than 1 year; and (4) body mass index between 25 and 42 kg/m2.
Exclusion criteria: Exclusion criteria were: (1) insulin therapy within the last 6 months; (2) concomitant cardiovascular diseases, psychological disorders, neurological problems, kidney or other endocrine disease; (3) drug abuse; (4) any intercurrent acute illness; (5) fasting glucose levels below 4 or above 19 mmol/L on the day of the experiment; and (6) treatment with glucocorticoids.
Age minimum:
28 Year(s)
Age maximum:
75 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nutritional, Metabolic, Endocrine
diabetes in developing countries
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Nutritional, Metabolic, Endocrine
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diabetes in developing countries
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Intervention(s)
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stevia rebaudiana as sweetener
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refined sugar (99% sucrose)
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Primary Outcome(s)
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Effect on hearth rate
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Effect on blood pressure (systolic, diastolic, mean)
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Effect on blood glucose
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Secondary Outcome(s)
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Arterial hypotension (less than mmHg 90 systolic or 60 diastolic)
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Hipoglycemia (capillary glucose less than 3.3 mmol/L)
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Source(s) of Monetary Support
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Centre de Cooperació al Desenvolupament URV Solidària(SEGEU)
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Ethics review
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Status: Approved
Approval date: 14/11/2012
Contact:
Radjem Research and Ethis Committee
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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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