Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study (OSEBERG)

Sykehuset i Vestfold HF

Status: Completed

Conditions: Morbid Obesity; Type 2 Diabetes

Treatments: Procedure: Sleeve gastrecomy; Procedure: Bastric bypass; Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01778738

2012/1427b

Details and patient eligibility

About

Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.

Full description

The Roux-en-Y gastric bypass operation combines restrictive and malabsorptive principles. It is the most commonly performed bariatric procedure worldwide (~ 50 %). Vertical (sleeve) gastrectomy on the other hand, is a purely restrictive procedure and has gained popularity and is now accepted as a valid procedure accounting for approximately five percent of the bariatric procedures performed worldwide.

The remission rate of type 2 diabetes one to two years after bariatric surgery is approximately 70%. Some studies have indicate that the remission rate of type 2 diabetes is higher after gastric bypass than after sleeve gastrectomy. Other studies indicate a similar effect on the reduction in HbA1c.

Weight reduction is comparable between gastric bypass and sleeve gastrectomy although some evidence suggets a larger weight loss following gastric bypass surgery. Larger weight loss can clearly contribute to somewhat greater improvement in glucose homeostasis after gastric bypass than after sleeve gastrectomy. Still, one might speculate that changes in gut hormones may contribute to higher remission rates of type 2 diabetes after gastric bypass than after sleeve gastrectomy.

Improved β-cell function observed after gastric bypass surgery may be linked to higher postprandial levels of Glucagonlike peptide 1 as seen after gastric bypass surgery. Beta cell function has, to our knowledge, only been addressed in one previous study after sleeve gastrectomy, with the authors reporting an increased first-phase insulin secretion three days after the procedure. Although several studies have addressed changes in gastrointestinal hormones the incretin effect on insulin secretion after gastric bypass has been estimated in only a few studies. To the best of our knowledge the incretin effect on insulin secretion after sleeve gastrectomy remains unexplored.We are aware of four ongoing randomised controlled trials comparing the effect of gastric bypass and sleeve gastrectomy on several endpoints including weight and comorbidities (ClinicalTrial.gov identifiers: NCT00722995, NCT00356213, NCT00793143, and NCT00667706). However, these studies include both subjects with and with-out type 2 diabetes and are therefore not powered to detect between-group differences in HbA1c and beta-cell function in the diabetic patients.

In conclusion, the effect of gastric bypass and sleeve gastrectomy on glycaemia is not fully elucidated. Moreover, the impact of altered beta-cell function post surgery needs to be explored. We hypothesise that greater improvement in beta-cell function after gastric bypass than after sleeve gastrectomy translates into better glycaemic control in subjects with type 2 diabetes one year after surgery.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Previously verified BMI ≥35.0 kg/m2 and current BMI ≥33.0 kg/m2
• HbA1c ≥6.5 % or use of anti-diabetic medications with HbA1c ≥6.1 %
• Age ≥18 years

Exclusion criteria

• Not able to give informed consent
• Previously major abdominal surgery (appendectomy, laparoscopic cholecystectomy or gynaecological procedures not included)
• Severe endocrine-, heart-, lung-, liver- and kidney disease, cancer and other medical conditions associated with significantly increased risk of peri- and postoperative complications
• Drug or alcohol addiction
• Reduced compliance due to severe mental and psychiatric conditions
• Pregnancy
• Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase (IA2)
• Regular use (a total of 3 months cumulative use in the last 12 months) or treatment the past two months with systemic corticosteroids
• Severe gastroesophageal reflux disease defined as Los Angeles classification grade > B, Barrett's oesophagus and/or hiatus hernia >5 cm
• Elevated esophageal pressure (DCI >5000 mmHg*sec*cm) and symptoms of dysphagia and/or painful swallowing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 3 patient groups

Sleeve gastrectomy

Experimental group

Description:

Sleeve gastrectomy.

Treatment:

Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Procedure: Sleeve gastrecomy

Gastric bypass

Experimental group

Description:

Gastric bypass surgery.

Treatment:

Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Procedure: Bastric bypass

Control group

No Intervention group

Description:

This is an extra control group without diabetes. All subjects are morbidly obese patients recruited from the Morbid Obesity Centre.