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Synergistic Effects of delta-Tocotrienol, Resveratrol and Vitamin D Supplementation on Modulation of Biochemical Markers, Cytokines and miRNAs in patients of type 2 diabetes mellitus -

SLCTR Registration Number

SLCTR/2018/019


Date of Registration

21 Jun 2018

The date of last modification

Jun 29, 2018



Application Summary


Scientific Title of Trial

Synergistic Effects of delta-Tocotrienol, Resveratrol and Vitamin D Supplementation on Modulation of Biochemical Markers, Cytokines and miRNAs in patients of type 2 diabetes mellitus


Public Title of Trial

Effects of delta-tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients


Disease of Health Condition(s) Studied

Type 2 Diabetes mellitus


Scientific Acronym

None


Public Acronym

None


Brief title

Effects of delta-tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients


Universal Trail Number

U1111-1215-3775


Any other number(s) assigned to the trial and issuing authority

Ethics Review Committee, Armed forces institute of pathology (AFIP); PhD-Path-18-02/Read-IRB/247


Trial Details


What is the research question being addressed?

Are delta tocotrienol, resveratrol and vitamin D combination effective in improving glyceamic control, reducing oxidative stress and inflammation in patients with type 2 diabetes mellitus?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

Study will be conducted at Armed forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan.

The diabetic patients after screening will be assigned to one of the five groups by simple randomization. Five groups consisting of four treatment arms A,B,C, D and one control arm E. Allocation concealment technique will not be used.

All participants (diabetic patients) will be provided nutritional supplements along with their recommended oral hypoglycemic medications.

Participants of Group A will be given one capsule of delta-tocotrienol (250 mg/ day); Group B resveratrol (200mg/day) ; Group C vitamin D (2500 IU/day); Group D combination preparation of tocotrienol, resveratrol & vitamin D (250mg+150mg+ 2500 IU per day) and Group E Placebo-(400mg, cellulose) by oral route for 24 weeks

Details of each allocation arm in the factorial assignment is as follow Arm 1: delta tocotrienol + placebo Arm 2: vitamin D + placebo Arm 3: resveratrol + placebo Arm 4: delta tocotrienol+ vitamin D+ resveratrol+ Placebo Arm 5: Placebo

Diabetic management standard protocol of dietary control and oral hypoglycemic agents will be given to each arm of patients.

Masking will be carried out as follows:
Participants: Blinded
Healthcare providers: Blinded


Inclusion criteria

  1. Pakistani male and female patients 18-70 years of age.
  2. Patients of diabetes mellitus type 2 having HbA1C 7-12 %
  3. Taking oral hypoglycemic agent for at least one year.
  4. Duration of diabetes > 5 years

Exclusion criteria

  1. Acute illness
  2. Chronic illness including chronic liver disease, Seropositive for HIV, Hepatitis B or Hepatitis C
  3. Chronic kidney diseases
  4. Uncontrolled hypertension. SBP of >180 mmHg and DBP >110 mmHg
  5. Thyroid disorders (TSH <0.3 or >5.5 µIU/mL) or thyroid malignancy
  6. BMI more than 35 kg/m2
  7. Medical history/clinical evidence of familial hyperlipidemic disorder.
  8. Pregnant or lactating women
  9. Taking insulin, statins, anti-inflammatory drugs, vitamin E and vitamin D regularly or in the last 4 weeks
  10. Unable to give informed consent


Primary outcome(s)

To determine the improvement in the glycemic control, reduction of oxidative stress and inflammation in the patients of type II diabetes mellitus by measuring following biochemical markers: 1. Mean reduction from baseline in glycosylated hemoglobin (HbA1c) at 24 weeks

  1. Mean reduction from baseline in Serum high sensitivity C reactive protein (hsCRP) at 24 weeks

  2. Mean reduction from baseline in Serum malondialdehyde (MDA) at 24 weeks


Primary outcome(s) - Time of assessment(s)

From baseline to 24 weeks of treatment within all groups


Secondary outcome

  1. Mean change in insulin resistance as measured by HOMA-IR
  2. Mean change in microalbuminuria
  3. Mean change in lipid profile
  4. Mean change in serum creatinine
  5. Mean change in cytokines [TNF-alpha (tumour necrosis factor alpha), interleukin (IL)-6, IL-10, IL-12, TGF-ß (Transforming growth factor-beta), Vascular endothelial growth factor (VEGF), Intercellular Adhesion Molecule (ICAM), Vascular cell adhesion molecule (VCAM)
  6. Mean change in circulatory mitochondrial RNA (miRNA): miRNA-21, miRNA-34a, miRNA-126, miRNA-132, miRNA-148, mi-RNA 217, miRNA-375

Secondary outcome(s) - Time of assessment(s)

  1. Mean change in insulin resistance as measured by HOMA-IR
  2. Mean change in microalbuminuria
  3. Mean change in lipid profile
  4. Mean change in serum creatinine
  5. Mean change in cytokines [TNF-alpha (tumour necrosis factor alpha), interleukin (IL)-6, IL-10, IL-12, TGF-ß (Transforming growth factor-beta), Vascular endothelial growth factor (VEGF), Intercellular Adhesion Molecule (ICAM), Vascular cell adhesion molecule (VCAM)
  6. Mean change in circulatory mitochondrial RNA (miRNA): miRNA-21, miRNA-34a, miRNA-126, miRNA-132, miRNA-148, mi-RNA 217, miRNA-375


Target number/sample size

275 individuals (55 patients in each group)


Countries of recruitment

Pakistan


Anticipated start date

2018-07-01


Anticipated end date

2019-01-31


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Armed forces institute of pathology (AFIP) on 5th April 2018 (Ref: PhD-Path-18-02/Read-IRB/247)


Funding source

Higher Education Commission (HEC), Pakistan



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
92-3005147938

dakhan@cpsp.edu.pk

Contact Person for Public Queries

Dr. Wajiha Mah Jabeen
PhD Scholar
Armed forces institute of Pathology (AFIP), National University of Medical Sciences (NUMS), Islamabad

03334219210

doctor_wajeeha@yahoo.com


Primary study sponsor/organization

Higher Education Commission (HEC) Pakistan

Head Office, Sector H-9, East Service Road, Islamabad Pakistan
Tel: (051) 9040 0000 (051) 9040 0000

info@hec.gov.pk
http://www.hec.gov.pk

Secondary study sponsor (If any)

None