type 2 diabetes. Non-insulin-dependent type 2 diabetes
Conditions
Interventions
Intervention 1: Placebo groups: Placebo,54 mg/day for3 month. Intervention 2: Intervention Group: 54 mg/day in two capsule for 3 month.
Placebo
Treatment - Drugs
Placebo groups: Placebo,54 mg/day for3 month
Intervention Group: 54 mg/day in two capsule for 3 month
Sponsors
Vice-chancellor for research, Tabriz Nutrition Research Center, Tabriz University of Medical Science
Eligibility
Sex/Gender
Female
Age
45 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Willingness to participate in the study; Postmenopausal women with history of at least one year menopause ; menopause must not be a complication of surgery; Type-2 diabetes for at least 6 months; using blood glucose lowering drugs (metformin) . Exclusion criteria: Unwillingness to participate in the study; Surgery leads to menopause; Early menopause (before 40 years); Use of androgen and estrogen and other steroids can affect the estrogen receptor; Insulin injections; Use of any nutritional supplements (omega-3) or anti-inflammatory and antioxidant supplements in the last 3 months or during the study; Liver and kidney failure, cardiovascular disease, breast cancer and thyroid disease; Smoking and alcohol; Patients taking NSAID, corticosteroids (prednisone, methylprednisolone, and hydrocortisone), antidiuretic thiazide (furosemide and hydrochlorothiazide) and anti psychotics second generation (olanzapine, clozapine and). (All participants in the study shouldn't take these drugs at least three months before the study)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indicators Blood Sugar (FBS, HbA1C, fasting insulin, insulin resistance and insulin sensitivity). Timepoint: Before and after intervention. Method of measurement: Fasting blood glucose by Spectrophotometry, serum insulin by ELISA and serum HbA1C measurements will be done by ion-exchange chromatography. As well as insulin resistance (HOMA-IR) and insulin sensitivity (QUICKI) will be calculated from formulas.;Serum lipid profile (TG, TC, HDL-C, LDL-C). Timepoint: Before and after the intervention. Method of measurement: Measuring TG, TC and HDL-C were performed using spectrophotometric methods. LDL-C levels were determined using the formula Fried-Wald.;Oxidative Stress (MDA, TAC). Timepoint: Before and after the intervention. Method of measurement: TAC and MDA measurements will be performed using spectrophotometry.;Weight, BMI, waist circumference, hip circumference and waist-to-hip ratio. Timepoint: Before and after the intervention. Method of measurement: Body weight will be measured without shoes and with minimal coverage by Seca scales with an accuracy of 0.1 kg Height, waist and hip are also measured by inelastic meters with an accuracy of 0.5 cm. For calculate of BMI will be used, BMI = weight (kg)/height (cm)2 and , waist-to-hip ratio was calculated, WHR = waist / hip. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity. Timepoint: before and after the intervention. Method of measurement: Physical Activity Questionnaire ipaq.;Energy and macronutrients intakes (carbohydrates, proteins and fats). Timepoint: before, End of sixth week and after the intervention. Method of measurement: Dietary record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHassan Braxas
Tabriz University Of Medical Sciences
Outcome results
None listed