Diabetes remission after metabolic gastric bypass, sleeve gastrectomy and greater curvature plicatio

Not Applicable

Completed

• Conditions: Morbid Obesity and Type 2 Diabetes Mellitus improvement after bariatric surgery; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14104758
• Lead Sponsor: Bellvitge Institute for Biomedical Research (IDIBELL)

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31375523/ results (added 01/07/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32737141/ (added 01/06/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32545353/ (added 15/02/2023) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31000783/ (added 15/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-02-28
• Study Start: 2016-01-25
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. GLP-1, glucagon, PYY, Ghrelin, glucose and insulin changes measured using a standard meal test at baseline, 1, 3 and 12 months<br> 2. Weight changes are measured using anthropometric techniques at baseline, 1, 3 and 12 months<br> 3. Body fat changes are measured using Dual-energy X-ray absorptiometry (DEXA) at baseline and 12 months<br> 4. Presence of GLP-1 receptors in adipose tissue is measured from a sample of visceral and subcutaneous adipose tissue at baseline<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of total, partial and non- T2DM remission is measured using Buse criteria at 12 months<br> 2. Blood pressure changes are measured using a sphygmomanometer at baseline and 12 months<br> 3. Plasma total cholesterol, HDL and triglycerides changes are measured from blood samples at baseline and 12 months<br> 4. Quality of life is measured using the Moorehead-Ardelt II test at 12 months<br>