Home » Trials » SLCTR/2014/014
Glycaemic response to a variety of fruits as mid-morning snack among Sri Lankan patients with Diabetes Mellitus under good glycaemic control- An interventional study.
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SLCTR Registration Number
SLCTR/2014/014
Date of Registration
The date of last modification
Apr 30, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Glycaemic response to a variety of fruits as mid-morning snack among Sri Lankan patients with Diabetes Mellitus under good glycaemic control- An interventional study.
Public Title of Trial
A study to determine blood glucose response to different fruits among Sri Lankan diabetic patients.
Disease or Health Condition(s) Studied
Diabetes Mellitus - type 2
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1159-4263
Any other number(s) assigned to the trial and issuing authority
EC-14-026 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What is the blood glucose response to six selected fruits available in Sri Lanka among Sri Lankan diabetic patients with good glycaemic control?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Crossover
Purpose
Basic science
Study Phase
Phase 2
Intervention(s) planned
The study will be conducted at the Department of Pharmacology, Faculty of Medicine, Colombo. Advertisements will be placed at the premises of the Faculty of Medicine, Colombo, inviting people with type 2 diabetes to participate in the study.Consenting participants meeting inclusion/exclusion criteria will be recruited. The study will be conducted in 6 rounds, each involving a standard portion of a selected fruit. At each round, participants will be requested to present to the study site at 8 a.m., without having breakfast. Bed tea will be permitted. At 8.00 a.m., a standard breakfast will be provided to all participants. At 10 a.m. a venous blood sample will be collected for pre-intervention plasma glucose measurement. At every interventional visit, patients will be randomly allocated one of three fruits. Each visit will take place twice a week (washout of 2-5 days). Then, a 50g edible portion of the selected fruit will be provided for consumption within 8-10 minutes. Participants will be requested to engage in light activities (e.g. walking, office work etc.) until 12 noon. Acceptable activities will be discussed with patients to ensure uniformity as much as possible. At 12 noon a second venous blood sample will be collected for post intervention plasma glucose measurement. This will be repeated for each round. The 6 selected fruits are banana , papaw, pineapple, kaamaranga (star fruit), mango and dragon fruit.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in plasma glucose 2 hours after intervention |
[ Plasma glucose will be measured at the following time points: 1. Fasting, 2. Two hours after the standard breakfast at each round 3. Two hours after the intervention (fruit intake) at each round ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
12
Countries of recruitment
Sri Lanka
Anticipated start date
2014-07-30
Anticipated end date
2014-08-30
Date of first enrollment
2014-07-23
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-06-19
Approval number
EC-14-026
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Kusum de Abrew
Professor
Department of Pharmacology, Faculty of Medicine, University of Colombo
0112697483
0718 655 662
0112697483
kusumdeabrew@yahoo.com
Contact Person for Public Queries
Prof. Kusum de Abrew
Professor
Department of Pharmacology, Faculty of Medicine, University of Colombo
0112697483
0718 655 662
0112697483
kusumdeabrew@yahoo.com
Primary study sponsor/organization
Department of Pharmacology, Faculty of Medicine, University of Colombo
0112697483
0112697483
http://www.med.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
