NCT03437902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

May 16, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 10, 2018

Last Update Submit

May 15, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetesRutinVitamin Coxidative stressInsulin resistancelipid profile

Outcome Measures

Primary Outcomes (3)

  • 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 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)) .

    Two months

Study Arms (3)

Rutin C group

EXPERIMENTAL

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

Vitamin C group

EXPERIMENTAL

patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.

Dietary Supplement: Vitamin C

Control group

NO INTERVENTION

patients will receive their usual antidiabetic treatment only for 8 weeks.

Interventions

Rutin in combination with Vitamin CDIETARY_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

Rutin C group
Vitamin CDIETARY_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.

Also known as: Ascorbic acid
Vitamin C group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31987106DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

RutinAscorbic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • sara R Ragheb, master

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 10, 2018

First Posted

February 19, 2018

Study Start

February 24, 2018

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

May 16, 2018

Record last verified: 2018-02

Locations

EG(1)