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NCT Number: NCT03437902

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rutin in combination with Vitamin C

Dietary Supplement

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

Vitamin C

Dietary Supplement

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 names: Ascorbic acid

Primary outcomes

  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 outcomes

  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)) .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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