NCT01778738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

December 3, 2012

Last Update Submit

April 18, 2023

Conditions

Type 2 DiabetesMorbid Obesity

Outcome Measures

Primary Outcomes (2)

  • Remission of type 2 diabetes.

    HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy

    One year

  • Beta-cell function

    Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.

    One Year

Secondary Outcomes (23)

  • Glycaemic control

    Five weeks to five years

  • Insulin secretion

    Five weeks to five years

  • Insulin sensitivity

    Five weeks to five years

  • Anti-diabetic medication

    Five weeks to five years

  • Body weight

    Five weeks to five years

  • +18 more secondary outcomes

Study Arms (3)

Sleeve gastrectomy

EXPERIMENTAL

Sleeve gastrectomy.

Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyProcedure: Sleeve gastrecomy

Gastric bypass

EXPERIMENTAL

Gastric bypass surgery.

Procedure: Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyProcedure: 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.

Interventions

Bariatric surgery, either gastric bypass surgery or sleeve gastrectomyPROCEDURE

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

Gastric bypassSleeve gastrectomy
Sleeve gastrecomyPROCEDURE

Vertical sleeve gastrectomy

Sleeve gastrectomy
Bastric bypassPROCEDURE

Gastric bypass surgery

Gastric bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Morbid Obesity Center, Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

Location

Related Publications (12)

  • 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.

    PMID: 31678062RESULT

  • Borgeraas 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.

    PMID: 31167860RESULT

  • Lorentzen 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.

    PMID: 32193740RESULT

  • Hofso 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.

    PMID: 33150385RESULT

  • Fatima 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.

    PMID: 34982397RESULT

  • Fatima 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.

    PMID: 34463768RESULT

  • Seeberg 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.

    PMID: 34843380RESULT

  • Lorentzen 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.

    PMID: 34419459RESULT

  • Wagen 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.

    PMID: 40185112DERIVED

  • Svanevik 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.

    PMID: 37414071DERIVED

  • Barstad 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.

    PMID: 36811476DERIVED

  • Seeberg 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.

    PMID: 36336684DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jøran Hjelmesæth, Professor

    Head of the Morbid Obesity Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinsipal Investigator

Study Record Dates

First Submitted

December 3, 2012

First Posted

January 29, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2019

Study Completion

November 1, 2022

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)