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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Rutin in combination with Vitamin C
* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rutin C group<br>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<br>* 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<br>|
| Experimental: Vitamin C group<br>patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks. | Dietary Supplement: Vitamin C<br>* 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.<br>* Other names: Ascorbic acid;|
| No Intervention: Control group<br>patients will receive their usual antidiabetic treatment only for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients | 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. | Two months | 
| Insulin resistance in diabetic patients . | 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 . | Two months | 
| Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c). | Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c). | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) . | 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)) . | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Rutin, Vitamin C, oxidative stress, Insulin resistance, lipid profile