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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01778738
Recruitment Status : Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Dag Hofsø, Sykehuset i Vestfold HF

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE January 29, 2013
Last Update Posted Date January 10, 2020
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • Remission of type 2 diabetes. [ Time Frame: One year ]
    HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy
  • Beta-cell function [ Time Frame: One Year ]
    Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
Remission of type 2 diabetes. HbA1c below or equal to 6.0 % without antidiabetes medication [ Time Frame: One year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • Glycaemic control [ Time Frame: Five weeks to five years ]
    HbA1c
  • 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.
  • 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.
  • Anti-diabetic medication [ Time Frame: Five weeks to five years ]
    Use of glucose lowering agents
  • Body weight [ Time Frame: Five weeks to five years ]
    Body weight (kg and kg/m2)
  • Body composition [ Time Frame: Five weeks to five years ]
    Measured by DEXA and bioelectrical impedance analysis
  • Blood pressure [ Time Frame: Five weeks to five years ]
    Resting and 24-h ambulatory systolic and diastolic blood pressure
  • 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.
  • Lipidemia [ Time Frame: Five weeks to five years ]
    Cholesterol and triglyceride levels
  • Obstructive sleep apnoea [ Time Frame: Five weeks to five years ]
    The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.
  • Proteinuria [ Time Frame: Five weeks to five years ]
    Urine protein-to-creatinine and albumin-to-creatinine ratios
  • 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.
  • Gastroesophageal motility disorders [ Time Frame: One to five years ]
    High-resolution manometry
  • 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.
  • Gut microbiota [ Time Frame: One to five years ]
    Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.
  • Physical activity [ Time Frame: Five weeks to five years ]
    Measured and self-reported physical activity
  • 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
  • Health related quality of life [ Time Frame: Five weeks to five years ]
    Short Form Quality of Life questionnaire (SF-36) v. 2.0
  • Obesity-related symptoms [ Time Frame: Five weeks to five years ]
    Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)
  • Psychological distress [ Time Frame: Five weeks to five years ]
    Beck Depression Inventory
  • Bone mineral density [ Time Frame: Five weeks to five years ]
    DEXA scan
  • Dumping syndrome [ Time Frame: Five weeks to five years ]
    Arts' questionnaire
  • Vitamin and mineral deficiencies [ Time Frame: Five weeks to five years ]
    Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • reduction in carotid-to-femoral pulse wave velocity (m/s)assessed with Spygmocor. [ Time Frame: 5 weeks and one year ]
  • weight loss (kg and BMI) [ Time Frame: one year ]
  • Reduction in nocurnal blood pressure (mmHg) assessed by ambulatory blood pressure monitoring [ Time Frame: 5 weeks and one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Morbid Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
  • No Intervention: Control group
    This is an extra control group without diabetes. All subjects are morbidly obese patients recruited from the Morbid Obesity Centre.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 1, 2018)
125
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)
120
Estimated Study Completion Date  ICMJE January 2023
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01778738
Other Study ID Numbers  ICMJE 2012/1427b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dag Hofsø, Sykehuset i Vestfold HF
Study Sponsor  ICMJE Sykehuset i Vestfold HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jøran Hjelmesæth, Professor Head of the Morbid Obesity Centre
PRS Account Sykehuset i Vestfold HF
Verification Date January 2020

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