SLCTR/2018/019.

Trial name or title	Acronym: ‐
Methods	Type of trial: efficacy trial Allocation: randomised Intervention model: parallel assignment Masking: double‐blinded (participants and healthcare providers) Primary purpose: treatment
Participants	Condition: type 2 diabetes mellitus Enrolment: estimated 275 Inclusion criteria Pakistani male and female participants 18 to 70 years of age Patients with type 2 diabetes mellitus having HbA1C 7% to 12% Taking oral hypoglycaemic agent for at least 1 year Duration of diabetes > 5 years Exclusion criteria Acute illness Chronic illness including chronic liver disease; seropositivity for HIV, hepatitis B, or hepatitis C Chronic kidney disease Uncontrolled hypertension (SBP > 180 mmHg and DBP > 110 mmHg) Thyroid disorders (TSH < 0.3 or > 5.5 µIU/mL) or thyroid malignancy BMI > 35 kg/m² Medical history/clinical evidence of familial hyperlipidaemic disorder Pregnant or lactating women Taking insulin, statins, anti‐inflammatory drugs, vitamin E, or vitamin D regularly or in the last 4 weeks Inability to give informed consent
Interventions	Intervention(s): resveratrol (200 mg/d) Comparator(s): placebo capsules
Outcomes	Primary outcome(s): mean reduction from baseline in serum high‐sensitivity C‐reactive protein (hsCRP), mean reduction from baseline in glycosylated haemoglobin (HbA1c), and mean reduction from baseline in serum malondialdehyde (MDA), at 24 weeks Secondary outcome(s): mean change in insulin resistance as measured by HOMA‐IR, mean change in microalbuminuria, mean change in lipid profile, mean change in serum creatinine, 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)), mean change in circulatory mitochondrial RNA (miRNA): miRNA‐21, miRNA‐34a, miRNA‐126, miRNA‐132, miRNA‐148, mi‐RNA 217, miRNA‐375 Other outcome(s): —
Starting date	Trial start date: July 2017 Trial completion date: January 2019 (estimated)
Contact information	Responsible party/principal investigator: Dr. Dilshad Ahmed Khan, National University of Medical Sciences (NUMS), Islamabad, Pakistan
Study identifier	Trial identifier:SLCTR/2018/019
Official title	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
Stated purpose of study	Quote: "effects of delta‐tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients"
Notes

— denotes not reported, ACE: angiotensin‐converting enzyme, ALT: alanine aminotransferase, AST: aspartate aminotransferase, BMI: body mass index, BP: blood pressure, GLP‐1: glucagon‐like peptide‐1, HbA1c: glycosylated haemoglobin A1c, HOMA‐IR: homeostasis model assessment of insulin resistance, NF‐Kb: nuclear factor kappa‐light‐chain‐enhancer of activated B cells, PPAR: peroxisome proliferator‐activated receptor, T2DM: type 2 diabetes mellitus, TSH: thyroid‐stimulating hormone.