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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201403000785219 Date of Approval: 07/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Gum Arabic on Type 2 Diabetes Mellitus
Official scientific title Effect of Gum Arabic (Acacia Senegal) consumption on adipokine level, metabolic syndrome elements and inflammatory cytokines among Type 2 Diabetes Mellitus patients
Brief summary describing the background and objectives of the trial Dibetes mellitus type 2 is a metabolic disorder of multiple aetiology characterized by peripheral insulin resistance and hyperinsulinaemia causing hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism as a result of defects of insulin secretion, its action or a combination of the two.In 1999 diagnostic criteria for diabetes was updated and modified by the World Health Organisation.Type 2 diabetes is commonly associated with a triad of medical disorders, these being obesity, hyperlipidaemia and hypertension, which have collectively become known as the ¿metabolic syndrome¿ or ¿syndrome X¿.Recent evidence indicates that inflammatory cytokines are elevated in patients with metabolic syndrome,thus suggesting a role for chronic inflammation as an underlying mechanism for progression of this disease. Various adipocyte-secreted factors have been described which profoundly affect insulin sensitivity and might potentially link obesity, insulin resistance, and cardiovascular diseaseGum Arabic was evaluated for acceptable daily intake for man by the Joint FAO/WHO Expert Committee on Food Additives since 1969. Several epidemiological studies suggest that a high intake of dietary fiber, including GA, is associated with beneficial effects on fat metabolism.Therefore a great opportunity for Gum Arabic to shift the equation of energy intake and utilization toward reduced fat storage holds to alter the course of human disease by the use of increasing range of adipocyte functions Objectives General objective The Aim of this study is to assess the effects of supplemented Gum Arabic (GA) on adipocyte hormones among type 2 diabetes mellitus patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GA Gum Arabic
Disease(s) or condition(s) being studied Diabetes Mellitus Type 2,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/04/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 31/10/2014
Actual Last follow-up date 30/09/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 124
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
SUM 116 -IRB number : 00008867 University of Medical Science and Technology (UMST) ethical committee
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Gum Arabic (Acacia Senegal) 45 gm / day in two divided doses 3 months a complex polysaccharide indigestible to both humans and animals. It has been considered as a safe dietary fiber by the United States, Food and Drug Administration (FDA) since the 1970s 62 Active-Treatment of Control Group
Control Group pectin 5 gm / day 3 months polysaccharide in ripe fruits 62 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Ages Eligible for Study ¿ 18 and < 75 Ages Eligible for Study ¿ 18 and < 75 Adult males and females Diagnosed NIDDM Fasting plasma glucose ¿7.0 mmol/L (126 mg/dl) HbA1c ¿ 6.5% On hypoglycaemic drug treatment. Females of childbearing on contraceptive method (A history of) metabolic or gastrointestinal diseases Chronic degenerative and/or inflammatory diseases Abuse of drugs and/or alcohol Diabetic on Insulin treatment. Type 1 diabetes mellitus (A history of) Gum Arabic (GA) allergy Pregnancy or planning to have a child within 6 months 18 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 Prof Abdalla O. Elkhawed- Dr. Hanan Tahir
Ethics Committee Address
Street address City Postal code Country
Rhyad street khartoum 00249 Sudan
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 12/01/2014 Prof.Abdalla.O.Elkhawed
Ethics Committee Address
Street address City Postal code Country
No.50-Block 3,Riyad, khartoum- Sudan khartoum 0024 Sudan
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 02/11/2014 Ministry of Health-Khartoum State Directorate of Research
Ethics Committee Address
Street address City Postal code Country
Nile street khartoum 0024 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the effect of Gum Arabic on the mean change of fasting plasma glucose and HbA1c Test Points 1: Start of the study. Test Points 2: 3 months from start.
Secondary Outcome To determine mean change of Lipid profile, BMI, waist circuference, hip circumference, WHR, VAI, BAI, DAAT, LAP, blood pressure and adiponectin Test point 1: start of study Test point 2: 3 months after start
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Academy charity teaching hospital (ACTH) Mohamed Nageeb street Khartoum 00249 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
UMST Rhiyad Khartoum 00249 Sudan
OWSD Strada Costiera Trieste 0039040 Italy
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UMST Rhiyad Khartoum 00249 Sudan University
Secondary Sponsor RCSI-Bahrain University
COLLABORATORS
Name Street address City Postal code Country
Dar Savanna Ltd. Ali Dinar street Khartoum 00249 Sudan
RCSI-Bahrain Adliya Manama 00973 Bahrain
UMST Rhiyad Khartoum 00249 Sudan
OWSD Strada Costiera Trieste 0039040 Italy
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasha Babiker rashat33@yahoo.com 00249912951517 Arkwait Block. 49, H.number 132, Africa street, Khartoum, Sudan
City Postal code Country Position/Affiliation
Khartoum 002499 Sudan physiology lecturer
Role Name Email Phone Street address
Public Enquiries Abdalla Elkhawad aoelkhawadster@gmail.com 00249918289619 No. 50 -Block 3,Al Riyad, al matar street, Khartoum, Sudan
City Postal code Country Position/Affiliation
Khartoum 002499 Sudan Dean Graduate College
Role Name Email Phone Street address
Scientific Enquiries Amal Saeed amalsaeed@yahoo.com +249-183-778570 Alqasr Street, 102, Khartoum-Sudan
City Postal code Country Position/Affiliation
Khartoum 002499 Sudan Physiology Associate professor
Role Name Email Phone Street address
Scientific Enquiries Khalifa Elmusharaf elmusharaf@rcsi-mub.com +973 17351450 Ext 3012 RCSI Bahrain P.O. Box 15503, Adliya, Kingdom of Bahrain
City Postal code Country Position/Affiliation
Bahrain Lecturer in Epidemiology & Public Health
Role Name Email Phone Street address
Scientific Enquiries Michael Keogh mkeogh@rcsi-mub.com +973 17351450 Ext 4053 RCSI Bahrain P.O. Box 15503, Adliya, Kingdom of Bahrain
City Postal code Country Position/Affiliation
Bahrain Lecturer in Human Biology & Research Laboratory Manager
REPORTING
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