Home » Trials » SLCTR/2019/024
Effects of Delta-Tocotrienol Supplementation on Glycemic Control in Prediabetic Patients
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SLCTR Registration Number
SLCTR/2019/024
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Effects of Delta-Tocotrienol Supplementation on Glycemic Control in Prediabetic Patients
Public Title of Trial
Efficacy of Delta-Tocotrienol vs Placebo on control of blood glucose level in prediabetic patients – A randomized controlled trial
Disease or Health Condition(s) Studied
Prediabetes
Scientific Acronym
None
Public Acronym
none
Brief title
Effects of Delta-Tocotrienol on Glycemic control in Prediabetic patients
Universal Trial Number
U1111-1224-9498
Any other number(s) assigned to the trial and issuing authority
MP-CHP17-14/READ-IRB/1479; ERC, AFIP Rawalpindi, Pakistan
What is the research question being addressed?
Is Delta-Tocotrienol effective in improving glycemic control in Prediabetic patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 1-2
Intervention(s) planned
Study setting: This study will be conducted at Maga Medical Complex/Armed Forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan.
Randomization: The prediabetic patients will be assigned to one of the two arms consisting of (A) intervention nutritional supplements (NS) and (B) control placebo (PS) arm by simple randomization.
Details of intervention: Patients in the NS arm will be assigned to receive nutritional supplement capsule (Delta-tocotrienol 300 mg) once daily orally for 12 weeks. Patients in PS arm will receive a matching placebo (cellulose 300 mg) for the same frequency and duration.
During the study period, participants in both arms will be requested to avoid consuming vitamin E, resveratrol or anti- inflammatory drugs.
Masking will be carried out as follows: Participants: Blinded Healthcare providers: Blinded
Inclusion criteria
Exclusion criteria
1.Cardiac patients 2.Pregnant or breast-feeding females 3.Critically ill patients 4. Acute stress/anxiety 5.Severe renal, liver or respiratory disease 5.Cancer patients 6.Those taking any medicine for glucose control
Primary outcome(s)
|
1.
1.Improvement of glycemic control including mean reduction in measurement of fasting plasma glucose (mmol/L) and HbA1c (mmol/L) at 12 weeks with baseline values |
[ At the baseline of the study and at 12 weeks after Delta-Tocotrienol supplementation (NS). ] |
Secondary outcome(s)
|
1.
Mean reduction in insulin resistance by measuring fasting blood glucose, (mmol/L), serum insulin (IU/L) and Homeostatic Model Assessment of Insulin Resistance (HOMA IR). |
[ At the baseline of the study and at 12 weeks after Delta-Tocotrienol supplementation (NS). ] |
Target number/sample size
70 (35 patients per arm)
Countries of recruitment
Pakistan
Anticipated start date
2019-07-15
Anticipated end date
2019-10-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National University of Medical Sciences Rawalpindi, Pakistan
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-03-12
Approval number
MP-CHP17-14/READ-IRB/1479
Details of Ethics Review Committee
| Name: | IRB Armed Force Institute of Pathology, Rawalpindi, Pakistan |
| Institutional Address: | Department of Chemical Pathology, Armed Forces Institute of Pathology, NUMS Pakistan |
| Telephone: | 92-51 5176397 |
| Email: | read.afip@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Dilshad Ahmed Khan
Professor of Pathology
National University of Medical Sciences (NUMS), Islamabad
0519270676
03005147938
dakhan@cpsp.edu.pk
Contact Person for Public Queries
Dr. Farhana Suleman
MPhil candidate
Armed forces institute of Pathology (AFIP), National University of Medical Sciences (NUMS), Islamabad
0519270676
92-3359023333
dr.farhanasuleman@gmail.com
Primary study sponsor/organization
National University of Medical Sciences Rawalpindi, Pakistan.
NUMS
mall road
03005147938
read.afip@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Study protocol, statistical analysis plan will be available. Data will be shared following publication of data. Researchers who provide a methodologically sound proposal will be provided with data. Data will be shared to achieve the aims in an approved proposal Data will be available for 5 years from the time of publication.
Study protocol available
No
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
