Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients

Overview

The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.

Full Title of Study: “Evaluation of the Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2018

Interventions

  • Dietary Supplement: Rutin in combination with Vitamin C
    • Rutin and Vitamin C will be supplied as tablets containing 60 mg Rutin and 160 mg Vitamin C. The use of Rutin and Vitamin C will be under the trade name of RUTA C 60 ® manufactured by KAHIRA PHARM.& CHEM. IND. Company
  • Dietary Supplement: Vitamin C
    • Vitamin C will be supplied as capsules containing500 mg of Vitamin C. The use of Vitamin C will be under the trade name of C-Retard ® manufactured by HIKMA Quality Company.

Arms, Groups and Cohorts

  • Experimental: Rutin C group
    • patients will receive Rutin 60 mg in combination with vitamin C 160 mg three times daily in addition to usual antidiabetic treatment for 8 weeks..
  • Experimental: Vitamin C group
    • patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.
  • No Intervention: Control group
    • patients will receive their usual antidiabetic treatment only for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients
    • Time Frame: Two months
    • Effect of Rutin and vitamin C combination or vitamin C alone on oxidative stress marker (MDA) and on antioxidant capacity (SOD) in diabetic patients after 8 weeks of treatment.
  • Insulin resistance in diabetic patients .
    • Time Frame: Two months
    • Effect of Rutin and vitamin C combination or vitamin C alone on insulin resistance in diabetic patients before i and after treatment for 8 weeks .
  • Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).
    • Time Frame: Two months
    • Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).

Secondary Measures

  • Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .
    • Time Frame: Two months
    • The effect of Rutin and vitamin C combination on quality of life of diabetic patients before and after treatment for 8 weeks and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .

Participating in This Clinical Trial

Inclusion Criteria

  • • Patients' age 35 years or older having type 2 diabetes mellitus. – Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin. – Able to understand and willing to sign a written informed consent document Exclusion Criteria:

  • • Pregnant and breast feeding females • use of vitamin supplements containing vitamin C or other antioxidants. – patients with renal or hepatic failure. – patients taking insulin as antidiabetic treatment

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: sara ramzy ragheb, Assistant Lecturer – Ain Shams University
  • Overall Official(s)
    • sara R Ragheb, master, Principal Investigator, Ain Shams University

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