diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants with type 2 diabetes Fasting blood glucose level = 126 mg/dL The two-hour plasma glucose level =200 mg/dL Consumption of oral hypoglycemic medications Body mass index (BMI) = 40 kg/m2 Completion of informed consent
Exclusion criteria
Exclusion criteria: Uncontrolled diabetes (HbA1C more than 9 mg/dl) Suffering from diabetic nephropathy History of ischemic heart disease pregnancy Lactation History of hospitalization for the treatment of heart disease during the last 6 months History of cancer treatment in the last 5 years Suffering from proteinuria History of steroid treatment during the last 3 months Suffering from thyroid disease History of lung disease and compliance with special diet Suffering from hepatitis Suffering from gastrointestinal disease Suffering from pancreatitis Suffering from inflammatory bowel disease Bowel resection Infected with AIDS Suffering from acute mental disorders Suffering from Cushing's syndrome Alcohol consumption Drug abuse Taking thiazide diuretics Taking antidepressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBA1C. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood test.;Fasting Plasma Glucose (FPG). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;Insulin. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;Insulin resistance index. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Formula.;Triacyl glyceride (TG). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;Total cholesterol. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;High Density Lipoprotein (HDL). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;Low Density Lipoprotein (LDL). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample.;Anxiety. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Beck validated questionnaire.;Depression. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Beck validated questionnaire.;Sleep quality. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pittsburgh validated questionnaire.;Quality of Life. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: SF-36 validated questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Height. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure.;Weight. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Weighting scale.;Body Mass Index (BMI). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer.;Waist circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure.;Hips circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure.;Fat mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer.;Fat free mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer.;Blood pressure. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Measurement of systolic and diastolic blood pressure (mmHg). | — |
Countries
Iran (Islamic Republic of)
Contacts
Yazd University of Medical Sciences