Type 2 DiabetesOSEBERGNCT01778738
Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study
A study testing Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Sleeve gastrecomy and Bastric bypass in people with Type 2 Diabetes and Morbid Obesity, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Morbid Obesity
- What is being tested?
- Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Sleeve gastrecomy and Bastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Morbid Obesity
- Being tested
- Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Sleeve gastrecomy, Bastric bypass
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyProcedure or surgery
Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention
Sleeve gastrecomyProcedure or surgery
Vertical sleeve gastrectomy
Bastric bypassProcedure or surgery
Gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Experimental | Sleeve gastrectomy. Receives: Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy; Procedure: Sleeve gastrecomy |
| Gastric bypass | Experimental | Gastric bypass surgery. Receives: Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy; Procedure: Bastric bypass |
| Control group | No intervention | This is an extra control group without diabetes. All subjects are morbidly obese patients recruited from the Morbid Obesity Centre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of type 2 diabetes.
HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy
Measured: One year
Beta-cell function
Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.
Measured: One Year
Secondary outcomes (23)
Glycaemic control
HbA1c
Measured: Five weeks to five years
Insulin secretion
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.
Measured: Five weeks to five years
Insulin sensitivity
Fasting and stimulated levels of glucose, insulin and C-peptide after an oral glucose load will be used for the calculation of insulin sensitivity.
Measured: Five weeks to five years
Anti-diabetic medication
Use of glucose lowering agents
Measured: Five weeks to five years
Body weight
Body weight (kg and kg/m2)
Measured: Five weeks to five years
Body composition
Measured by DEXA and bioelectrical impedance analysis
Measured: Five weeks to five years
Blood pressure
Resting and 24-h ambulatory systolic and diastolic blood pressure
Measured: Five weeks to five years
Pulse wave velocity
The Sphygmocor system (Artcor, Sidney, Australia) and a single high-fidelity applanation tonometer (Millar®) will be used to measure pulse wave velocity.
Measured: Five weeks to five years
Lipidemia
Cholesterol and triglyceride levels
Measured: Five weeks to five years
Obstructive sleep apnoea
The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.
Measured: Five weeks to five years
Proteinuria
Urine protein-to-creatinine and albumin-to-creatinine ratios
Measured: Five weeks to five years
Gastroesophageal reflux disease
Gastroesophageal reflux disease will be diagnosed using upper endoscopy, 24 hour intra-oesophageal pH monitoring and symptom scores.
Measured: One to five years
Gastroesophageal motility disorders
High-resolution manometry
Measured: One to five years
Fatty liver disease
MRI (Siemens Aera 1.5 T) and Chemical Shift Imaging18 will be used to quantify the fat-fraction content of the liver.
Measured: One to five years
Gut microbiota
Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.
Measured: One to five years
Physical activity
Measured and self-reported physical activity
Measured: Five weeks to five years
Energy intake and eating behaviour
Food frequency questionnaire, food tolerance questionnaire, power of food scale and binge eating scale
Measured: Five weeks to five years
Health related quality of life
Short Form Quality of Life questionnaire (SF-36) v. 2.0
Measured: Five weeks to five years
Obesity-related symptoms
Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)
Measured: Five weeks to five years
Psychological distress
Beck Depression Inventory
Measured: Five weeks to five years
Bone mineral density
DEXA scan
Measured: Five weeks to five years
Dumping syndrome
Arts' questionnaire
Measured: Five weeks to five years
Vitamin and mineral deficiencies
Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.
Measured: Five weeks to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2019
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dag Hofsø, Sykehuset i Vestfold HF
- Investigators
- Jøran Hjelmesæth, Professor, Study chair, Head of the Morbid Obesity Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778738
- Sponsor's protocol ID
- 2012/1427b
- Acronym
- OSEBERG
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2012
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):912-924. doi: 10.1016/S2213-8587(19)30344-4. Epub 2019 Oct 31.
PubMed 31678062Borgeraas H, Hjelmesaeth J, Birkeland KI, Fatima F, Grimnes JO, Gulseth HL, Halvorsen E, Hertel JK, Hillestad TOW, Johnson LK, Karlsen TI, Kolotkin RL, Kvan NP, Lindberg M, Lorentzen J, Nordstrand N, Sandbu R, Seeberg KA, Seip B, Svanevik M, Valderhaug TG, Hofso D. Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and beta-cell function in subjects with morbid obesity: a protocol for the Obesity surgery in Tonsberg (Oseberg) study. BMJ Open. 2019 Jun 4;9(6):e024573. doi: 10.1136/bmjopen-2018-024573.
PubMed 31167860Lorentzen J, Medhus AW, Hertel JK, Borgeraas H, Karlsen TI, Kolotkin RL, Sandbu R, Sifrim D, Svanevik M, Hofso D, Seip B, Hjelmesaeth J. Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without Type 2 Diabetes: a Cross-sectional Study. Obes Surg. 2020 Jul;30(7):2667-2675. doi: 10.1007/s11695-020-04545-w.
PubMed 32193740Hofso D, Hillestad TOW, Halvorsen E, Fatima F, Johnson LK, Lindberg M, Svanevik M, Sandbu R, Hjelmesaeth J. Bone Mineral Density and Turnover After Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial (Oseberg). J Clin Endocrinol Metab. 2021 Jan 23;106(2):501-511. doi: 10.1210/clinem/dgaa808.
PubMed 33150385Fatima F, Hjelmesaeth J, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hofso D. Validation of Ad-DiaRem and ABCD Diabetes Remission Prediction Scores at 1-Year After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in the Randomized Controlled Oseberg Trial. Obes Surg. 2022 Mar;32(3):801-809. doi: 10.1007/s11695-021-05856-2. Epub 2022 Jan 4.
PubMed 34982397Fatima F, Hjelmesaeth J, Birkeland KI, Gulseth HL, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hartmann B, Holst JJ, Hofso D. Gastrointestinal Hormones and beta-Cell Function After Gastric Bypass and Sleeve Gastrectomy: A Randomized Controlled Trial (Oseberg). J Clin Endocrinol Metab. 2022 Jan 18;107(2):e756-e766. doi: 10.1210/clinem/dgab643.
PubMed 34463768Seeberg KA, Borgeraas H, Hofso D, Smastuen MC, Kvan NP, Grimnes JO, Lindberg M, Fatima F, Seeberg LT, Sandbu R, Hjelmesaeth J, Hertel JK. Gastric Bypass Versus Sleeve Gastrectomy in Type 2 Diabetes: Effects on Hepatic Steatosis and Fibrosis : A Randomized Controlled Trial. Ann Intern Med. 2022 Jan;175(1):74-83. doi: 10.7326/M21-1962. Epub 2021 Nov 30.
PubMed 34843380Lorentzen J, Medhus AW, Hofso D, Svanevik M, Seip B, Hjelmesaeth J. Sleeve Gastrectomy Confers Higher Risk of Gastroesophageal Reflux Disease Than Gastric Bypass: A Randomized Controlled Trial From the Oseberg Reflux Working Group. Gastroenterology. 2021 Dec;161(6):2044-2046.e4. doi: 10.1053/j.gastro.2021.08.021. Epub 2021 Aug 20. No abstract available.
PubMed 34419459Wagen Hauge J, Borgeraas H, Birkeland KI, Johnson LK, Hertel JK, Hagen M, Gulseth HL, Lindberg M, Lorentzen J, Seip B, Kolotkin RL, Svanevik M, Valderhaug TG, Sandbu R, Hjelmesaeth J, Hofso D. Effect of gastric bypass versus sleeve gastrectomy on the remission of type 2 diabetes, weight loss, and cardiovascular risk factors at 5 years (Oseberg): secondary outcomes of a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2025 May;13(5):397-409. doi: 10.1016/S2213-8587(24)00396-6. Epub 2025 Apr 1.
PubMed 40185112Svanevik M, Lorentzen J, Borgeraas H, Sandbu R, Seip B, Medhus AW, Hertel JK, Kolotkin RL, Smastuen MC, Hofso D, Hjelmesaeth J. Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Aug;11(8):555-566. doi: 10.1016/S2213-8587(23)00127-4. Epub 2023 Jul 3.
PubMed 37414071Barstad LH, Johnson LK, Borgeraas H, Hofso D, Svanevik M, Smastuen MC, Hertel JK, Hjelmesaeth J. Changes in dietary intake, food tolerance, hedonic hunger, binge eating problems, and gastrointestinal symptoms after sleeve gastrectomy compared with after gastric bypass; 1-year results from the Oseberg study-a randomized controlled trial. Am J Clin Nutr. 2023 Mar;117(3):586-598. doi: 10.1016/j.ajcnut.2022.11.016. Epub 2022 Dec 22.
PubMed 36811476Seeberg KA, Hofso D, Borgeraas H, Grimnes JO, Fatima F, Seeberg LT, Kvan NP, Svanevik M, Hertel JK, Hjelmesaeth J. Association between hepatic steatosis and fibrosis with measures of insulin sensitivity in patients with severe obesity and type 2 diabetes - a cross-sectional study. BMC Gastroenterol. 2022 Nov 7;22(1):448. doi: 10.1186/s12876-022-02550-0.
PubMed 36336684
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01778738
- Acronym / sponsor ID
- OSEBERG / 2012/1427b
- Conditions
- Type 2 Diabetes, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | Experimental | Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Procedure: Sleeve gastrecomySleeve gastrectomy. |
| Gastric bypass | Experimental | Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Procedure: Bastric bypassGastric bypass surgery. |
| Control group | No intervention | –This is an extra control group without diabetes. All subjects are morbidly obese patients recruited from the Morbid Obesity Centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyVertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention | Procedure or surgery | Gastric bypass, Sleeve gastrectomy |
| Sleeve gastrecomyVertical sleeve gastrectomy | Procedure or surgery | Sleeve gastrectomy |
| Bastric bypassGastric bypass surgery | Procedure or surgery | Gastric bypass |
Primary outcome
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.
23 secondary outcomes
Glycaemic control
Time frame: Five weeks to five years
Insulin secretion
Time frame: Five weeks to five years
Insulin sensitivity
Time frame: Five weeks to five years
Anti-diabetic medication
Time frame: Five weeks to five years
Body weight
Time frame: Five weeks to five years
Body composition
Time frame: Five weeks to five years
Blood pressure
Time frame: Five weeks to five years
Pulse wave velocity
Time frame: Five weeks to five years
Lipidemia
Time frame: Five weeks to five years
Obstructive sleep apnoea
Time frame: Five weeks to five years
Proteinuria
Time frame: Five weeks to five years
Gastroesophageal reflux disease
Time frame: One to five years
Gastroesophageal motility disorders
Time frame: One to five years
Fatty liver disease
Time frame: One to five years
Gut microbiota
Time frame: One to five years
Physical activity
Time frame: Five weeks to five years
Energy intake and eating behaviour
Time frame: Five weeks to five years
Health related quality of life
Time frame: Five weeks to five years
Obesity-related symptoms
Time frame: Five weeks to five years
Psychological distress
Time frame: Five weeks to five years
Bone mineral density
Time frame: Five weeks to five years
Dumping syndrome
Time frame: Five weeks to five years
Vitamin and mineral deficiencies
Time frame: Five weeks to five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Results publication: PubMed 31678062Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):912-924. doi: 10.1016/S2213-8587(19)30344-4. Epub 2019 Oct 31.
- Results publication: PubMed 31167860Borgeraas H, Hjelmesaeth J, Birkeland KI, Fatima F, Grimnes JO, Gulseth HL, Halvorsen E, Hertel JK, Hillestad TOW, Johnson LK, Karlsen TI, Kolotkin RL, Kvan NP, Lindberg M, Lorentzen J, Nordstrand N, Sandbu R, Seeberg KA, Seip B, Svanevik M, Valderhaug TG, Hofso D. Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and beta-cell function in subjects with morbid obesity: a protocol for the Obesity surgery in Tonsberg (Oseberg) study. BMJ Open. 2019 Jun 4;9(6):e024573. doi: 10.1136/bmjopen-2018-024573.
- Results publication: PubMed 32193740Lorentzen J, Medhus AW, Hertel JK, Borgeraas H, Karlsen TI, Kolotkin RL, Sandbu R, Sifrim D, Svanevik M, Hofso D, Seip B, Hjelmesaeth J. Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without Type 2 Diabetes: a Cross-sectional Study. Obes Surg. 2020 Jul;30(7):2667-2675. doi: 10.1007/s11695-020-04545-w.
- Results publication: PubMed 33150385Hofso D, Hillestad TOW, Halvorsen E, Fatima F, Johnson LK, Lindberg M, Svanevik M, Sandbu R, Hjelmesaeth J. Bone Mineral Density and Turnover After Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial (Oseberg). J Clin Endocrinol Metab. 2021 Jan 23;106(2):501-511. doi: 10.1210/clinem/dgaa808.
- Results publication: PubMed 34982397Fatima F, Hjelmesaeth J, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hofso D. Validation of Ad-DiaRem and ABCD Diabetes Remission Prediction Scores at 1-Year After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in the Randomized Controlled Oseberg Trial. Obes Surg. 2022 Mar;32(3):801-809. doi: 10.1007/s11695-021-05856-2. Epub 2022 Jan 4.
- Results publication: PubMed 34463768Fatima F, Hjelmesaeth J, Birkeland KI, Gulseth HL, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hartmann B, Holst JJ, Hofso D. Gastrointestinal Hormones and beta-Cell Function After Gastric Bypass and Sleeve Gastrectomy: A Randomized Controlled Trial (Oseberg). J Clin Endocrinol Metab. 2022 Jan 18;107(2):e756-e766. doi: 10.1210/clinem/dgab643.
- Results publication: PubMed 34843380Seeberg KA, Borgeraas H, Hofso D, Smastuen MC, Kvan NP, Grimnes JO, Lindberg M, Fatima F, Seeberg LT, Sandbu R, Hjelmesaeth J, Hertel JK. Gastric Bypass Versus Sleeve Gastrectomy in Type 2 Diabetes: Effects on Hepatic Steatosis and Fibrosis : A Randomized Controlled Trial. Ann Intern Med. 2022 Jan;175(1):74-83. doi: 10.7326/M21-1962. Epub 2021 Nov 30.
- Results publication: PubMed 34419459Lorentzen J, Medhus AW, Hofso D, Svanevik M, Seip B, Hjelmesaeth J. Sleeve Gastrectomy Confers Higher Risk of Gastroesophageal Reflux Disease Than Gastric Bypass: A Randomized Controlled Trial From the Oseberg Reflux Working Group. Gastroenterology. 2021 Dec;161(6):2044-2046.e4. doi: 10.1053/j.gastro.2021.08.021. Epub 2021 Aug 20. No abstract available.
- Derived from this study: PubMed 40185112Wagen Hauge J, Borgeraas H, Birkeland KI, Johnson LK, Hertel JK, Hagen M, Gulseth HL, Lindberg M, Lorentzen J, Seip B, Kolotkin RL, Svanevik M, Valderhaug TG, Sandbu R, Hjelmesaeth J, Hofso D. Effect of gastric bypass versus sleeve gastrectomy on the remission of type 2 diabetes, weight loss, and cardiovascular risk factors at 5 years (Oseberg): secondary outcomes of a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2025 May;13(5):397-409. doi: 10.1016/S2213-8587(24)00396-6. Epub 2025 Apr 1.
- Derived from this study: PubMed 37414071Svanevik M, Lorentzen J, Borgeraas H, Sandbu R, Seip B, Medhus AW, Hertel JK, Kolotkin RL, Smastuen MC, Hofso D, Hjelmesaeth J. Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Aug;11(8):555-566. doi: 10.1016/S2213-8587(23)00127-4. Epub 2023 Jul 3.
- Derived from this study: PubMed 36811476Barstad LH, Johnson LK, Borgeraas H, Hofso D, Svanevik M, Smastuen MC, Hertel JK, Hjelmesaeth J. Changes in dietary intake, food tolerance, hedonic hunger, binge eating problems, and gastrointestinal symptoms after sleeve gastrectomy compared with after gastric bypass; 1-year results from the Oseberg study-a randomized controlled trial. Am J Clin Nutr. 2023 Mar;117(3):586-598. doi: 10.1016/j.ajcnut.2022.11.016. Epub 2022 Dec 22.
- Derived from this study: PubMed 36336684Seeberg KA, Hofso D, Borgeraas H, Grimnes JO, Fatima F, Seeberg LT, Kvan NP, Svanevik M, Hertel JK, Hjelmesaeth J. Association between hepatic steatosis and fibrosis with measures of insulin sensitivity in patients with severe obesity and type 2 diabetes - a cross-sectional study. BMC Gastroenterol. 2022 Nov 7;22(1):448. doi: 10.1186/s12876-022-02550-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jøran Hjelmesæth, Professor study chair
Head of the Morbid Obesity Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Sleeve gastrecomy and Bastric bypass in people with Type 2 Diabetes and Morbid Obesity, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of type 2 diabetes. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778738, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.