Type 2 diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: Patients in this group will receive L-citrulline supplement for 8 weeks. The supplement is a sachet containing 3 grams of L-Citrulline (a product by Bulk Supplement
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: Suffering from type 2 diabetes that have passed at least 6 months since diagnosis and having HbA1c less than 9. Men and non-menopausal women Age 25 to 55 years BMI 25 to 35 kg/m2 People who control their diabetes just by using metformin and sulfonylurea Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Pregnancy, lactation or menopause in women Smoking or alcohol use A history of following a particular diet (at the time of the study or 3 months before the study) Change in the type or dosage of medications consumed, the type and amount of physical activity, changes in the diet at the start and during the study Using synthetic or herbal drugs for weight loss Use of any supplement (L-arginine, glutamine, multivitamin, antioxidant supplement, etc.) during the three months before or during the study. Taking insulin Suffering from cardiovascular disease, liver, intestinal, thyroid and parathyroid dysfunction, polycystic ovary syndrome, cancers and malignant diseases such as sprue and Crohn's disease Having symptoms of infectious or inflammatory disease or recent surgery The use of hypotensive and lipid-lowering drugs Use of corticosteroids and non-steroidal anti-inflammatory drugs for 3 months before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric Indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2).;Calorie and macronutrients intake. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program.;Fasting blood sugare. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method.;Insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.;HbA1c. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method.;Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation.;Insulin resistance. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405.;Oxidative stress indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total antioxidant capacity, glutathione peroxidase, superoxide dismutase and malondialdehyde through spectrophotometric method.;Inflammatory indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6, TNF-a, MCP1 and TLR4 by ELISA.;Serum levels of L-Citrulline. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.;Serum nitrate and nitrite (NOx). Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via IPAQ questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSamaneh Azizi
Tabriz University of Medical Sciences
Outcome results
None listed