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 January 2013 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: January 25, 2013
Last verified: January 2013

December 3, 2012
January 25, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
Remission of type 2 diabetes. HbA1c below or equal to 6.0 % without antidiabetes medication [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778738 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Hypertension
  • Weight
  • 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
  • Procedure: Bastric bypass
    Gastric bypass surgery
  • Experimental: Sleeve gastrectomy
    Sleeve gastrectomy
    Interventions:
    • Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy
    • Procedure: Sleeve gastrecomy
  • Experimental: Gastric bypass
    gastric bypass surgery
    Interventions:
    • Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy
    • Procedure: Bastric bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2020
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Jøran Hjelmesæth, MD, PhD +47 40217349 joran.hjelmeseth@siv.no
Norway
 
NCT01778738
2012/1427b
No
Njord Nordstrand, Sykehuset i Vestfold HF
Sykehuset i Vestfold HF
Not Provided
Not Provided
Sykehuset i Vestfold HF
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP