Type 2 diabetic patients. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group: receives 550 mg daily of hydro-alcoholic extract of fumaria Parviflora for 2 months. Intervention 2: Control group: receive 550 mg daily of placebo consisting of co
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who agree to participate in the study Women aged 20 to 50 years (non-menopausal) and men 20 to 65 years BMI range between 25 and 40 kg /m2 ; Having type 2 diabetes for at least 6 months while taking blood sugar-lowering drugs (metformin and thiazolidine )
Exclusion criteria
Exclusion criteria: Reluctance to participate in the study Insulin injection Use any nutritional supplements such as omega-3 supplements or supplements that have anti-inflammatory and antioxidant properties in the past 3 months or during the study Liver and kidney failure and thyroid diseases Smoking and alcohol consumption Patients using NSAIDs, corticosteroids (prednisone, prednisolone, and hydrocortisone), thiazide (furosemide and hydrochlorothiazide), and second-generation antipsychotics (olanzapine and clozapine). Pregnancy and desire to conceive during the study Intestinal and gastrointestinal diseases and eating disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intercellular Adhesion Molecule 1?. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test.;Total antioxidant capacity. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests.;Malondialdehyde. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests.;Glutathione peroxidase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests.;Superoxide dismutase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests.;Catalase. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood tests.;MCP-1gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method.;Nf-kB gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method.;BAX gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method.;Nrf-2 gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method.;BCL-2 gene expression. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Measurement of gene expression by RT-PCR method.;Total cholesterol. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test.;Triglyceride. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test.;High-density lipoprotein. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test.;Low-density lipoprotein. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Blood Test.;Atherogenic index of plasma. Timepoint: Baseline and 2 months after the intervention. Method of m | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric indecs. Timepoint: Baseline and 2 months after the intervention. Method of measurement: Body composition measuring device.;Antropometric indices (Weight, Height, BMI, Waist circumference, Hip circumference, Waist to Hip Ratio). Timepoint: Baseline and 2 months after the intervention. Method of measurement: Physical exam. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Farzad Najafipour
Tabriz University of Medical Sciences
Outcome results
None listed