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.: PACTR202009486614518 Date of Approval: 03/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exercise and fasting glucose
Official scientific title Is fasting glucose in monitoring glycaemic burden significantly affected by prolonged walking to the clinic?
Brief summary describing the background and objectives of the trial Single glucose measurements are widely used for monitoring of glycaemic burden and titration of therapy in Sub-Saharan Africa due to resource constraints and the effect of comorbidities on HbA1c performance. Many people with diabetes in Uganda and other SSA countries walk long distances to the diabetes clinics, and it is unclear whether this affects the validity of fasting glucose measurement as a measure of overall glycemic control. This study aims to assess the impact of walking on fasting glucose measures. We will assess the impact of prolonged walking on fasting glucose in 42 participants in comparison to rest, with exercise and rest performed in random order. This study is part of a larger observational study (OPTIMAL) assessing the performance of different measures of glycemic monitoring in the Ugandan setting, and the risk of hypoglycemia (low blood glucose) in this population.
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 01/11/2019
Actual trial start date 14/11/2019
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Experimental Group Exercise 1 hour of moderate walking pace (4.5 km/hr) on a treadmill followed by two hours of resting (minimal physical activity) 3 hours Participants will be provided with transport to come to the clinic in a fasting state before 9 am. A cannula will be inserted for blood taking and fasting blood sample taken. Participants will start exercising at a moderate walking pace of 4.5 km/hr on a treadmill for 1 hour. Samples will be taken for laboratory glucose measurement at 0, 30 and 60 minutes, and post-exercise every 30 minutes for a further 2 hours (3 hours total monitoring). The participants will be provided with a meal and take usual morning medication at the end of the visit. 42
Control Group Rest visit 1 visit Participants will rest/perform minimal physical activity for 3 hours Participants will attend in a fasting state before 9 am (as above). A cannula will be inserted for blood taking and fasting blood sample taken. Participants will be asked to rest/perform minimal physical activity. Samples will be taken for laboratory glucose measurement at 0, 30 and 60 minutes, every 30 minutes for a further 2 hours (3 hours total monitoring). The participants will be provided with a meal and take usual morning medication at the end of the visit. 42 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Clinical diagnosis of type 2 diabetes 2. Age at diagnosis >18 years 3. >3 months’ diabetes duration 4. No initial insulin requirement for ≥ 1 year since the time of diagnosis 5. No change in glucose-lowering therapy in the previous 3 months at the time of screening 6. Able to give informed consent and willing to participate in study-related procedures 1. Current pregnancy 2. Critically ill patients that need admission 3. Need an immediate increase of their glucose-lowering medication or insulin 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 25649 Uganda
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 11/06/2019 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera road Ntinda Kampala 06884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The modelled difference in glucose baseline, 0.5, 1, 1.5, 2, 2.5, 3 hours
Secondary Outcome 1) The difference in mean glucose change at all time- points 2) Time to lowest glucose Baseline, 0.5, 1, 1.5, 2, 2.5, 3 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Masaka Regional Referral Hospital Masaka Masaka Uganda
St. Francis Hospital Nsambya Nsambya Road Nsambya Hill/ Box 7146 Nsambya Rd Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
NIHR Global Health Research Project University of Exeter Exeter United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Exeter NIHR Clinical Research Facility Room 2.15 RILD Building RDE Hospital Wonford Barrack Road Exeter United Kingdom Hospital
Secondary Sponsor MRC UVRI and LSHTM Research Unit Plot 51-59 Nakiwogo road Entebbe 00049 Uganda Research Unit
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anxious Jackson Niwaha an464@exeter.ac.uk +256077520840 Plot 51-59 Nakiwogo road
City Postal code Country Position/Affiliation
Entebbe 00049 Uganda PhD fellow
Role Name Email Phone Street address
Scientific Enquiries Angus Jones Angus.Jones@exeter.ac.uk +447733228100 NIHR Clinical Research Facility Room 2.15 RILD Building RDE Hospital Wonford Barrack Road
City Postal code Country Position/Affiliation
Exeter United Kingdom Ass. Professor
Role Name Email Phone Street address
Scientific Enquiries Moffat Nyirenda moffat.nyirenda@lshtm.ac.uk +2560750753242 Plot 51-59 Nakiwogo road
City Postal code Country Position/Affiliation
Entebbe 00049 Uganda Head NCD Theme Lead
Role Name Email Phone Street address
Scientific Enquiries Beverley Shields B.Shields@exeter.ac.uk +447849881795 NIHR Clinical Research Facility Room 2.15 RILD Building RDE Hospital Wonford Barrack Road
City Postal code Country Position/Affiliation
Exeter United Kingdom Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Lauren Rodgers L.R.Rodgers@exeter.ac.uk +447764499148 NIHR Clinical Research Facility Room 2.15 RILD Building RDE Hospital Wonford Barrack Road EX2 5DW
City Postal code Country Position/Affiliation
Exeter United Kingdom Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual Study Protocol IPD will be available within 10 months of article publication for 2 years. Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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