Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201410000894447 Date of Registration: 28/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and cost of Stevia rebaudiana Bertoni extract as adjunctive therapy in Sahrawi patients with Type 2 diabetes
Official scientific title Efficacy of Stevia rebaudiana Bertoni extract as adjunctive therapy in Sahraoui patients with Type 2 diabetes. A Randomized, Controlled, Cross-over, Double-Blind Trial
Brief summary describing the background and objectives of the trial Aims: Stevioside, isolated in pure form from the plant Stevia rebaudiana Bertoni (SrB), has beneficial effects on hyperglycaemia and hypertension according to several studies. However, little experimental work has been performed to prove these effects in less expensive dry extract of plant. This study aimed to assess its efficacy and cost as tea sweetener to reduce blood glucose and mean arterial pressure in Sahrawi patients with Type 2 diabetes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diabetes in developing countries,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2013
Actual trial start date 05/01/2013
Anticipated date of last follow up 14/06/2014
Actual Last follow-up date 02/09/2014
Anticipated target sample size (number of participants) 79
Actual target sample size (number of participants) 114
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised random number electronic table sealed opaque envelope Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group refined sugar (99% sucrose) 10 grams one intake one ingestion before starting experiment 114 Active-Treatment of Control Group
Experimental Group stevia rebaudiana as sweetener 9 grams one one ingestion before starting experiment 114 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. 28 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/11/2012 Radjem Research and Ethis Committee
Ethics Committee Address
Street address City Postal code Country
Marché des Chameaux sn Lâayounne 70000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect on hearth rate Were determined hearth rate at minutes 0 (baseline), 30, 60, 120 and 240 after the ingestion.
Primary Outcome Effect on blood pressure (systolic, diastolic, mean) Were determined blood pressure at minutes 0 (baseline), 30, 60, 120 and 240 after the ingestion
Secondary Outcome Arterial hypotension (less than mmHg 90 systolic or 60 diastolic) Were measured in minutes 0 (baseline), 30, 60, 120 and 240
Primary Outcome Effect on blood glucose Were determined capillary blood glucose at minutes 0 (baseline), 30, 60, 120 and 240 after the ingestion.
Secondary Outcome Hipoglycemia (capillary glucose less than 3.3 mmol/L) Were measured in minutes 0 (baseline), 30, 60, 120 and 240
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Radjem Clinic Marché des Chameaux sn Lâayounne 70000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Centre de Cooperació al Desenvolupament URV Solidària(SEGEU) SalutSant Llorenç, 21 Reus 43201 Spain
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Angela Pallarés Provenza 159 Barcelona 08034 Spain University
COLLABORATORS
Name Street address City Postal code Country
Genís Carrasco Provenza 161 Barcelona 08036 Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angela Pallarés angelapallares@telefonica.net 0034659500976 Provenza 159
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Professor
Role Name Email Phone Street address
Public Enquiries Genís Carrasco geniscarrasco@telefonica.net 0034626550055 Provenza 159
City Postal code Country Position/Affiliation
Barcelona 08034 Spain Clinical chief, statistics and communication
Role Name Email Phone Street address
Scientific Enquiries Genís Carrasco geniscarrasco@telefonica.net 0034626550055 Provenza 159
City Postal code Country Position/Affiliation
B 08036 Spain Clinical chief and statistics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information