Home » Trials » SLCTR/2019/024


Effects of Delta-Tocotrienol Supplementation on Glycemic Control in Prediabetic Patients

-

SLCTR Registration Number

SLCTR/2019/024


Date of Registration

12 Jul 2019

The date of last modification

Jul 13, 2019



Application Summary


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


Trial Details


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

  • Both men and women
  • Aged 18-60 years
  • Participants who are diagnosed to have Prediabetic criteria: a. Impaired fasting plasma glucose level (5.6-6.9mmol/L) or/and b. Glycosylated hemoglobin (HbA1c) 5.7% to 6.4%

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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