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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437902
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
sara ramzy ragheb, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Rutin in combination with Vitamin C Dietary Supplement: Vitamin C Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
Actual Study Start Date : February 24, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
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..
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

Experimental: Vitamin C group
patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.
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.
Other Name: Ascorbic acid

No Intervention: Control group
patients will receive their usual antidiabetic treatment only for 8 weeks.



Primary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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 Outcome Measures :
  1. 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)) .



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437902


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: sara R Ragheb, master Ain Shams University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: sara ramzy ragheb, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03437902    
Other Study ID Numbers: PHCL39
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by sara ramzy ragheb, Ain Shams University:
Type 2 diabetes
Rutin
Vitamin C
oxidative stress
Insulin resistance
lipid profile
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Vitamins
Ascorbic Acid
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents