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. 2020 Jan 17;2020(1):CD011919. doi: 10.1002/14651858.CD011919.pub2

IRCT20171118037528N1.

Trial name or title Acronym:
Methods Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: double‐blinded (participants and administrators)
Primary purpose: treatment
Participants Condition: type 2 diabetes mellitus
Enrolment: estimated 72
Inclusion criteria
  • Patients with type 2 diabetes who have been diagnosed for at least 3 months

  • 30 to 60 years of age

  • BMI 24 to 30 kg/m²


Exclusion criteria
  • Clinical diagnosis of any liver, kidney, cancer, or Alzheimer disease

  • Insulin therapy

  • HbA1c = 8%

  • Consumption of any anti‐oxidant supplements in the last 6 months

  • History of allergic reaction to grapes

  • Consumption of anti‐coagulants

  • Fibrates and aspirin

  • Drinking red wine and alcohol

  • History of myocardial infraction

  • Presence of stent or battery in the heart

  • Gastrointestinal ulcer

  • Pregnancy or lactation

  • Following the unusual diet until 1 month before the study

  • Unwillingness to participate in the study

Interventions Intervention(s): resveratrol (500 mg oral 2 times a day)
Comparator(s): placebo capsules
Outcomes Primary outcome(s): peroxisome proliferator‐activated receptor alpha, p53 gene, p21 gene, p16 gene, soluble cluster of differentiation 163, TNF‐related weak inducer of apoptosis
Secondary outcome(s): total triglycerides, total cholesterol, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, fasting blood glucose, glycated haemoglobin, fasting insulin
Other outcome(s):
Starting date Trial start date: July 2018
Trial completion date: not reported
Contact information Responsible party/principal investigator: Shima Abdollahi, Shahid Sadoughi University of Medical Science
Study identifier Trial identifier:IRCT20171118037528N1
Official title Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ratio in T2DM patients
Stated purpose of study Quote: "effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ratio in T2DM patients"
Notes