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

• Register: ISRCTN
• Last refreshed on: 27 February 2023
• Main ID: ISRCTN14104758
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: Bellvitge Institute for Biomedical Research (IDIBELL)
• Public title: Diabetes remission after metabolic gastric bypass, sleeve gastrectomy and greater curvature plication
• Scientific title: Prognostic factors and pathophysiology of type 2 diabetes mellitus remission following bariatric surgery. gastric bypass, sleeve gastrectomy and greater curvature plication: A randomised controlled trial
• Date of first enrolment: 10/05/2012
• Target sample size: 45
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14104758
• Study type: Interventional
• Study design: Single-centre non-blinded randomised parallel trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Nuria Vilarrasa Garcia

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 gastric bypass, a mixed bariatric technique (restrictive pouch and a biliopancreatic limb length of 200cm and alimentary limb of 100cm)
Group 2: Participants undergo a sleeve gastrectomy, a restrictive technique performed over a 36Fr bougie
Group 3: Participants undergo gastric plication, a restrictive technique without gastrectomy and no bowel derivation. It is a greater gastric curvature invagination with two running non absorbable suture, over a 36Fr bougie.

The same surgeon performs all the procedures by laparoscopy. Study participants attend visits at baseline and 1, 3 and 12 months after the three surgical techniques. Postoperative diet progression and medical follow-up is the same for all patients. At each visit, anthropometric and biochemical parameters including glucose, HbA1c, and lipid profile are determined. A study of body composition with DEXA is conducted at baseline and at 12 months after surgery. A standard meal test for determination of plasma GLP-1, glucagon, PYY, ghrelin, insulin and glucose is performed at baseline and at 1 and 12 months after surgery. During the intervention a sample of visceral and subcutaneous adipose tissue is collected.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

PI11/01960

Source(s) of Monetary Support

Bellvitge Institute for Biomedical Research (IDIBELL)

Ethics review

Status:
Approval date:
Contact:

Bellvitge's Clinical Research and Ethics Committee from Barcelona, 26/01/2012, ref: PI11/01960

Results

• Results available: Yes
• Date Completed: 28/02/2015