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.: PACTR202007803347704 Date of Approval: 31/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a low and high carbohydrate evening meal on oral glucose tolerance in people in Sub Saharan Africa; a randomized cross over study
Official scientific title The effect of a low and high carbohydrate evening meal on oral glucose tolerance in people in Sub Saharan Africa; a randomized cross over study
Brief summary describing the background and objectives of the trial We will undertake a randomized cross-over study to determine whether the carbohydrate content of the meal the night before an Oral Glucose Tolerance Test (OGTT) effects the results of this test. Participants will be recruited from the MRC/UVRI & LSHTM Uganda Research Unit’s cohort population in rural Uganda. The results of the study will help inform the utility of the OGTT in epidemiological studies and in diagnosis of diabetes in regions with high levels of food insecurity and a rising prevalence of diabetes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/07/2019
Actual trial start date 01/07/2020
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date 01/09/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal then small evening meal 2 meals in one day 1 day followed by a one week washout period This is a randomized cross-over study involving 40 healthy adults who will be recruited from a cohort population in rural Uganda. The participants will report to the health facility having fasted overnight on two occasions. On arrival they will have an OGTT followed by a standard lunch. In the evening they will be given either a normal or a very small evening meal and observed overnight. The next morning another OGTT will be performed. Glucose and insulin results from these OGTT will be compared. 40 Uncontrolled
Experimental Group Small then normal evening meal 2 meals in one day 1 day followed by one week washout period This is a randomized cross over study involving 40 participants. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults aged 18 years to less than 70 years of age 2. No history of diagnosis of diabetes 3. Able and willing to participate in the study and provide informed consent 1. Anticipated medication change in the 8 days of the test 2. Known pregnant women Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 29/03/2019 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
Plot 51 - 59 Nakiwogo Road Entebbe 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome The secondary end point of interest is the difference in insulin secretion response between the two meals. day after the meals
Primary Outcome The difference in Fasting and 2 hour glucose between the two meals. Day after the meals
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Uganda Virus and Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit Plot 51-59 Nakiwogo Road Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health Research 79 Whitehall Room 132 Richmond House LONDON 00044 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MRC UVRI and LSHTM Uganda Research Unit 51 59 Nakiwogo Road Entebbe 00256 Uganda Research Unit
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moffat Nyirenda moffat.nyirenda@lshtm.ac.uk +256750753242 51 59 Nakiwogo Road
City Postal code Country Position/Affiliation
Kampala 00256 Uganda Principal Investigator
Role Name Email Phone Street address
Public Enquiries Wisdom Nakanga wisdomnakanga@gmail.com +256705834945 51 59 Nakiwogo Road
City Postal code Country Position/Affiliation
Kampala 00256 Uganda Investigator
Role Name Email Phone Street address
Scientific Enquiries Wisdom Nakanga wisdomnakanga@gmail.com +256705834945 51 59 Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe 00256 Uganda Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data that underlie the results after de-identification including text, tables, figures, and appendices will be shared Study Protocol The data will be available immediately following publication and the end date for the availability has not been set Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be included No
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