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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sykehuset i Vestfold HF
Sponsor:
Information provided by (Responsible Party):
Njord Nordstrand, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT01778738
First received: December 3, 2012
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Hypertension
Weight
Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy
Procedure: Sleeve gastrecomy
Procedure: Bastric bypass
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • Remission of type 2 diabetes. HbA1c below or equal to 6.0 % without antidiabetes medication [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction in carotid-to-femoral pulse wave velocity (m/s)assessed with Spygmocor. [ Time Frame: 5 weeks and one year ] [ Designated as safety issue: No ]
  • weight loss (kg and BMI) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Reduction in nocurnal blood pressure (mmHg) assessed by ambulatory blood pressure monitoring [ Time Frame: 5 weeks and one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI ≥ 35 kg/m2
  • Type 2 diabetes with current HbA1c ≥ 6.5 % or use of oral anti-diabetic medications
  • Age ≥ 18 years

Exclusion Criteria:

. Treatment with insulin or GLP-1 agonist the past two months

  • Previous bariatric surgery
  • Previously major abdominal surgery (appendectomy, cholecystectomy and 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
  • Severe mental and psychiatric conditions associated with significantly reduced compliance
  • Pregnancy
  • Barrett's oesophagus
  • Reflux disease with continuous use of proton pump inhibitors
  • 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 oral or inhalation corticosteroids
  • Medication suspected to influence insulin secretion and action such as unselective β-blockers
  • Not able to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778738

Contacts
Contact: Jøran Hjelmesæth, MD, PhD +47 40217349 joran.hjelmeseth@siv.no

Locations
Norway
The Morbid Obesity Center, Vestfold Hospital Trust Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Njord Nordstrand, MD    +47 92603276    njord.nordstrand@siv.no   
Contact: Dag Hofsø, MD, PhD    +47 90591666    dag.hofso@siv.no   
Principal Investigator: Jøran Hjelmesæth, MD. PhD         
Principal Investigator: Dag Hofsø, Md, PhD         
Principal Investigator: Njord Nordstrand, MD, PhD fellow         
Sponsors and Collaborators
Sykehuset i Vestfold HF
  More Information

No publications provided

Responsible Party: Njord Nordstrand, MD, PhD fellow, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01778738     History of Changes
Other Study ID Numbers: 2012/1427b
Study First Received: December 3, 2012
Last Updated: November 18, 2014
Health Authority: Norway: Regional Ethics Commitee, South East

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014