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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sleeve gastrectomy

Sleeve gastrectomy.

Group Type EXPERIMENTAL

Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Intervention Type PROCEDURE

Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention

Sleeve gastrecomy

Intervention Type PROCEDURE

Vertical sleeve gastrectomy

Gastric bypass

Gastric bypass surgery.

Group Type EXPERIMENTAL

Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Intervention Type PROCEDURE

Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention

Bastric bypass

Intervention Type PROCEDURE

Gastric bypass surgery

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention

Intervention Type PROCEDURE

Sleeve gastrecomy

Vertical sleeve gastrectomy

Intervention Type PROCEDURE

Bastric bypass

Gastric bypass surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No