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

April 18, 2023 updated by: Dag Hofsø, Sykehuset i Vestfold HF

Glycaemia, Insulin Secretion and Action in Morbidly Obese Subjects With Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3103
        • The Morbid Obesity Center, Vestfold Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleeve gastrectomy
Sleeve gastrectomy.
Procedure: 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
Procedure: Sleeve gastrecomy
Vertical sleeve gastrectomy
Experimental: Gastric bypass
Gastric bypass surgery.
Procedure: 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
Procedure: Bastric bypass
Gastric bypass surgery
No Intervention: Control group
This is an extra control group without diabetes. All subjects are morbidly obese patients recruited from the Morbid Obesity Centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of type 2 diabetes.
Time Frame: One year
HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy
One year
Beta-cell function
Time Frame: One Year
Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic control
Time Frame: Five weeks to five years
HbA1c
Five weeks to five years
Insulin secretion
Time Frame: Five weeks to five years
Fasting and stimulated levels of glucose, insulin, C-peptide and proinsulin after an oral glucose load will be used for the calculation of insulin secretion.
Five weeks to five years
Insulin sensitivity
Time Frame: Five weeks to five years
Fasting and stimulated levels of glucose, insulin and C-peptide after an oral glucose load will be used for the calculation of insulin sensitivity.
Five weeks to five years
Anti-diabetic medication
Time Frame: Five weeks to five years
Use of glucose lowering agents
Five weeks to five years
Body weight
Time Frame: Five weeks to five years
Body weight (kg and kg/m2)
Five weeks to five years
Body composition
Time Frame: Five weeks to five years
Measured by DEXA and bioelectrical impedance analysis
Five weeks to five years
Blood pressure
Time Frame: Five weeks to five years
Resting and 24-h ambulatory systolic and diastolic blood pressure
Five weeks to five years
Pulse wave velocity
Time Frame: Five weeks to five years
The Sphygmocor system (Artcor, Sidney, Australia) and a single high-fidelity applanation tonometer (Millar®) will be used to measure pulse wave velocity.
Five weeks to five years
Lipidemia
Time Frame: Five weeks to five years
Cholesterol and triglyceride levels
Five weeks to five years
Obstructive sleep apnoea
Time Frame: Five weeks to five years
The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.
Five weeks to five years
Proteinuria
Time Frame: Five weeks to five years
Urine protein-to-creatinine and albumin-to-creatinine ratios
Five weeks to five years
Gastroesophageal reflux disease
Time Frame: One to five years
Gastroesophageal reflux disease will be diagnosed using upper endoscopy, 24 hour intra-oesophageal pH monitoring and symptom scores.
One to five years
Gastroesophageal motility disorders
Time Frame: One to five years
High-resolution manometry
One to five years
Fatty liver disease
Time Frame: One to five years
MRI (Siemens Aera 1.5 T) and Chemical Shift Imaging18 will be used to quantify the fat-fraction content of the liver.
One to five years
Gut microbiota
Time Frame: One to five years
Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.
One to five years
Physical activity
Time Frame: Five weeks to five years
Measured and self-reported physical activity
Five weeks to five years
Energy intake and eating behaviour
Time Frame: Five weeks to five years
Food frequency questionnaire, food tolerance questionnaire, power of food scale and binge eating scale
Five weeks to five years
Health related quality of life
Time Frame: Five weeks to five years
Short Form Quality of Life questionnaire (SF-36) v. 2.0
Five weeks to five years
Obesity-related symptoms
Time Frame: Five weeks to five years
Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)
Five weeks to five years
Psychological distress
Time Frame: Five weeks to five years
Beck Depression Inventory
Five weeks to five years
Bone mineral density
Time Frame: Five weeks to five years
DEXA scan
Five weeks to five years
Dumping syndrome
Time Frame: Five weeks to five years
Arts' questionnaire
Five weeks to five years
Vitamin and mineral deficiencies
Time Frame: Five weeks to five years
Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.
Five weeks to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset i Vestfold HF

Investigators

  • Study Chair: Jøran Hjelmesæth, Professor, Head of the Morbid Obesity Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1427b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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