Morbid Obesity and Type 2 Diabetes Mellitus improvement after bariatric surgery Nutritional, Metabolic, Endocrine Morbid Obesity and Type 2 Diabetes Mellitus improvement after bariatric surgery
Conditions
Interventions
Patients are randomly assigned (1:1:1) to three groups using envelope stratification according to the presence of an initial hba1c > or < 7%.
Group 1: Participants undergo a metabolic
Sponsors
Bellvitge Institute for Biomedical Research (IDIBELL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years 2. BMI of 35-42Kg/m2 3. Diagnosis of type 2 diabetes mellitus (T2DM)
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Diabetes secondary to pancreatic injury or other disease (Cushing's syndrome or acromegaly) 3. Presence of GAD auto-antibodies 4. Acute metabolic complications (ketosis, ketoacidosis or hyperosmolar state over the last six months) 5. Serious infection that can affect blood glucose control during the 4 weeks prior inclusion 6. Cardiovascular events (heart failure, angina pectoris, myocardial infarction or stroke) within 6 months prior to inclusion 7. History of liver disease (chronic active hepatitis or cirrhosis) and/or abnormal liver function (ALT and/or AST 3 times above the upper normal value) 8. Altered renal function (creatinine >1.4 mg/dl in women and 1.5 mg/dl in men) 9. Patients with anticoagulant therapy 10. Congenital or acquired abnormalities of the digestive tract (atresia, stenosis) 11. Pregnancy, nursing or desired pregnancy in the 12 months following the inclusion 12. Recent history of neoplasm (<5 years) except basal cell skin cancer 13. Glucocorticoid use by oral or intravenous route for more than 14 consecutive days in the last three months prior to inclusion 14. Alcoholism, drug addiction or major psychiatric disorder 15. Patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. GLP-1, glucagon, PYY, Ghrelin, glucose and insulin changes measured using a standard meal test at baseline, 1, 3 and 12 months 2. Weight changes are measured using anthropometric techniques at baseline, 1, 3 and 12 months 3. Body fat changes are measured using Dual-energy X-ray absorptiometry (DEXA) at baseline and 12 months 4. Presence of GLP-1 receptors in adipose tissue is measured from a sample of visceral and subcutaneous adipose tissue at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of total, partial and non- T2DM remission is measured using Buse criteria at 12 months 2. Blood pressure changes are measured using a sphygmomanometer at baseline and 12 months 3. Plasma total cholesterol, HDL and triglycerides changes are measured from blood samples at baseline and 12 months 4. Quality of life is measured using the Moorehead-Ardelt II test at 12 months | — |
Countries
Spain
Outcome results
None listed