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

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ClinicalTrials.gov Identifier: NCT01778738
Recruitment Status : Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dag Hofsø, Sykehuset i Vestfold HF

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Morbid Obesity Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy Procedure: Sleeve gastrecomy Procedure: Bastric bypass Not Applicable

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  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : January 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Remission of type 2 diabetes. [ Time Frame: One year ]
    HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy

  2. Beta-cell function [ Time Frame: One Year ]
    Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.


Secondary Outcome Measures :
  1. Glycaemic control [ Time Frame: Five weeks to five years ]
    HbA1c

  2. 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.

  3. 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.

  4. Anti-diabetic medication [ Time Frame: Five weeks to five years ]
    Use of glucose lowering agents

  5. Body weight [ Time Frame: Five weeks to five years ]
    Body weight (kg and kg/m2)

  6. Body composition [ Time Frame: Five weeks to five years ]
    Measured by DEXA and bioelectrical impedance analysis

  7. Blood pressure [ Time Frame: Five weeks to five years ]
    Resting and 24-h ambulatory systolic and diastolic blood pressure

  8. 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.

  9. Lipidemia [ Time Frame: Five weeks to five years ]
    Cholesterol and triglyceride levels

  10. Obstructive sleep apnoea [ Time Frame: Five weeks to five years ]
    The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.

  11. Proteinuria [ Time Frame: Five weeks to five years ]
    Urine protein-to-creatinine and albumin-to-creatinine ratios

  12. 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.

  13. Gastroesophageal motility disorders [ Time Frame: One to five years ]
    High-resolution manometry

  14. 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.

  15. Gut microbiota [ Time Frame: One to five years ]
    Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.

  16. Physical activity [ Time Frame: Five weeks to five years ]
    Measured and self-reported physical activity

  17. 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

  18. Health related quality of life [ Time Frame: Five weeks to five years ]
    Short Form Quality of Life questionnaire (SF-36) v. 2.0

  19. Obesity-related symptoms [ Time Frame: Five weeks to five years ]
    Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)

  20. Psychological distress [ Time Frame: Five weeks to five years ]
    Beck Depression Inventory

  21. Bone mineral density [ Time Frame: Five weeks to five years ]
    DEXA scan

  22. Dumping syndrome [ Time Frame: Five weeks to five years ]
    Arts' questionnaire

  23. Vitamin and mineral deficiencies [ Time Frame: Five weeks to five years ]
    Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778738


Locations
Norway
The Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Vestfold, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
Investigators
Study Chair: Jøran Hjelmesæth, Professor Head of the Morbid Obesity Centre

Responsible Party: Dag Hofsø, Prinsipal Investigator, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01778738     History of Changes
Other Study ID Numbers: 2012/1427b
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms