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NCT Number: NCT01778738

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Morbid Obesity Center, Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy

Procedure

Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention

Sleeve gastrecomy

Procedure

Vertical sleeve gastrectomy

Bastric bypass

Procedure

Gastric bypass surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Registry information

Official study 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

Acronym: OSEBERG

Important dates

Study start
2013
Primary completion
2019
Study completion
2022
First posted
Jan 29, 2013
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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