Condition 1: Diabetes. Condition 2: Morbid obesity. Diabetes mellitus due to underlying condition Morbid (severe) obesity due to excess calories
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Candidate for Roux-en Y surgery Satisfaction to participate in the study Age over 18 years Body mass index more or equal to 40 and less or equal to 50
Exclusion criteria
Exclusion criteria: History of major gastrointestinal surgery Having general conditions that prevent surgery under general anesthesia Age over 75 years Having Crohn's inflammatory disease Family history of gastric cancer Severe intestinal adhesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excess Body Mass Index Loss (EBMIL). Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Using the following formula obtained from the body mass index: (Pre-operative BMI – Current BMI) / (Pre-operative BMI – 25) × 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes remission. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Using Buchwald criteria (FPG <100 mg/dl or A1C <6 %).;Insulin. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Fasting blood sugar. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Glocuse, 2 hour Post Prandial. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;C-Peptide. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;HbA1C. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Lipid profile. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Systolic blood presser. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Barometer.;Diastolic blood pressure. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Barometer.;Dumping. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Physical examination.;Hemoglobin. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Liver porfile. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling.;Quality of life. Timepoint: Six months after the intervention. Method of measurement: BAROS quality of life consisting of 5 items (self-esteem, work conditions, physical activity, social activity and sexual Activity). Each item consists of 5 options (much better, be | — |
Countries
Iran (Islamic Republic of)
Contacts
Iran University of Medical Sciences