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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Vitamin C; Dietary Supplement: Rutin in combination with Vitamin C

• Registration Number: NCT03437902
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-02-24
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C group	Vitamin C	patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.
Rutin C group	Rutin in combination with Vitamin C	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..

Primary Outcome Measures

Name	Time	Method
Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients	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 .	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).	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

Name	Time	Method
Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .	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)) .

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt