Back to resultsImpact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Rutin in combination with Vitamin C
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, Rutin, Vitamin C, oxidative stress, Insulin resistance, lipid profile
Eligibility 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
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Rutin C group
Vitamin C group
Control group
Arm Description
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..
patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.
patients will receive their usual antidiabetic treatment only for 8 weeks.
Outcomes
Primary Outcome Measures
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.
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 .
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).
Secondary Outcome Measures
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)) .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03437902
Brief Title
Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes, Rutin, Vitamin C, oxidative stress, Insulin resistance, lipid profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rutin C group
Arm Type
Experimental
Arm Description
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..
Arm Title
Vitamin C group
Arm Type
Experimental
Arm Description
patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients will receive their usual antidiabetic treatment only for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rutin in combination with Vitamin C
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients
Description
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.
Time Frame
Two months
Title
Insulin resistance in diabetic patients .
Description
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 .
Time Frame
Two months
Title
Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).
Description
Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .
Description
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)) .
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sara R Ragheb, master
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
31987106
Citation
Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14.
Results Reference
derived
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Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
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