NCT02710786

Brief Summary

To evaluate effect on comorbid disease and weight loss in the long-term (\>five years) after Roux-en-Y gastric bypass (RYGB) surgery for severe obesity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2007

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

17.7 years

First QC Date

February 18, 2016

Last Update Submit

December 18, 2023

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in comorbid conditions, as defined by use of pharmacological treatment

    Remission of diabetes mellitus, hypertension, dyslipidemia, and depression as defined by use of pharmacological treatment, and sleep apnea as defined by use of CPAP. Data will be collected from SOReg.

    10 years

Secondary Outcomes (3)

  • Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions)

    10 years

  • Weight loss

    10 years

  • BMI loss

    10 years

Study Arms (1)

Gastric bypass

Patients undergoing gastric bypass

Procedure: Gastric bypass

Interventions

Gastric bypassPROCEDURE

Gastric bypass surgery, i.e., small gastric pouch and excluded main stomach

Gastric bypass

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals undergoing gastric bypass

You may qualify if:

  • Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass

You may not qualify if:

  • All other operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Ingemar Näslund

    Scandinavian Obesity Surgery Registry

    STUDY CHAIR

Central Study Contacts

Erik Näslund

CONTACT

erik.naslund@ki.se

Magnus Sundbom

CONTACT

magnus.sundbom@surgsci.uu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 17, 2016

Study Start

May 1, 2007

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)