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

Phase 4

Recruiting

Conditions: Type 2 Diabetes mellitus

Registration Number: SLCTR/2018/019

Lead Sponsor: Higher Education Commission (HEC) Pakistan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>1. Mean reduction from baseline in glycosylated hemoglobin (HbA1c) at 24 weeks <br><br>2. Mean reduction from baseline in Serum high sensitivity C reactive protein (hsCRP) at 24 weeks <br><br>3. Mean reduction from baseline in Serum malondialdehyde (MDA) at 24 weeks [From baseline to 24 weeks of treatment within all groups]<br>

Secondary Outcome Measures

Name	Time	Method
Mean change in insulin resistance as measured by HOMA-IR<br><br>2. Mean change in microalbuminuria<br><br>3. Mean change in lipid profile<br><br>4. Mean change in serum creatinine<br><br>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)<br><br>6. Mean change in circulatory mitochondrial RNA (miRNA): miRNA-21, miRNA-34a, miRNA-126, miRNA-132, miRNA-148, mi-RNA 217, miRNA-375 [From baseline to 24 weeks of treatment within all groups]<br>