Effect of Cornus Mas L. fruit extract on patients with type 2 diabetes mellitus

Not Applicable

• Conditions: Type 2 diabetes.; Diabetes mellitus; E10-E14

• Registration Number: IRCT201305059662N6
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Background.TheplantCornus masL. (cornelian cherry) is traditionally used as an antidiabetic supplement; however, there is no<br /> related clinical trial. In this study, we evaluated the effects of the fruit extract of this plant on biomarkers of glycemic control in adult<br /> patients with type 2 diabetes.Methods. Sixty patients with type 2 diabetes were randomly assigned to two groups to receive either the<br /> extract or placebo capsules (2 capsules twice daily) for 6 weeks. Each drug capsule contained 150 mg of anthocyanins. Fasting plasma<br /> levels of glucose, insulin, HgbA<br /> 1C<br /> , and triglyceride as well as 2-hour postprandial glucose level (2Hpp) were measured before and<br /> after the intervention and finally the mean values were compared between groups.Results. After 6 weeks of intervention, significant<br /> increase in insulin level (1.13 ±1.90 versus-0.643±1.82,

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Type 2 diabetes mellitus patients (according to America Diabetes Association ADA); glycosylated hemoglobin levels above 7% and less than 12%; subjects between the ages 18 to 80 years; No alcohol and other drug abuse; Does not change the dose of anti-diabetic medication within 1 month
Exclusion criteria: Individuals with a history of diseases; liver and kidney; with the medication use affecting blood sugar levels; pregnant and breastfeeding; hypersensitivity to the drug used in this study; the incidence of diabetic foot ulcers; heart disease, severe systolic blood pressure = 180 and / or pressure diastolic = 110

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FBS level. Timepoint: Baseline and after 6 weeks. Method of measurement: By autoanalyzer.;Hgb A1C level. Timepoint: Baseline and after 6 weeks. Method of measurement: By autoanalyzer.

Secondary Outcome Measures

Name	Time	Method
Serum creatinine. Timepoint: Before and after 6 weeks. Method of measurement: By autoanalyzer.;Alanine transaminase (ALT). Timepoint: Before and after 6 weeks. Method of measurement: By autoanalyzer.;Aspartate transaminase (AST). Timepoint: Before and after 6 weeks. Method of measurement: By autoanalyzer.;Length. Timepoint: Before and after 6 weeks. Method of measurement: meter.;Weight. Timepoint: Before and after 6 weeks. Method of measurement: Scale.