Comorbidity After Gastric Bypass

December 18, 2023 updated by: Uppsala University

Long-term Resolution of Comorbidites After Gastric Bypass

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals with severe obesity frequently have comorbid diseases, e.g. diabetes, hypertension, hyperlipidemia, and sleep apnea. We will study the remission rate and weight loss in the long-term (10 years) after Roux-en-Y gastric bypass (RYGB) surgery in a nationwide large group of patients.

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals undergoing gastric bypass

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • All other operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric bypass
Patients undergoing gastric bypass
Procedure: Gastric bypass
Gastric bypass surgery, i.e., small gastric pouch and excluded main stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in comorbid conditions, as defined by use of pharmacological treatment
Time Frame: 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions)
Time Frame: 10 years
Glucose, HbA1c, LDL, HDL, triglycerides, and blood pressure
10 years
Weight loss
Time Frame: 10 years
Peroperative weight (in kg) minus current weight (in kg)
10 years
BMI loss
Time Frame: 10 years
Peroperative BMI minus current BMI. Weight and height will be combined to report BMI in kg/m^2.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
The Scandinavian Obesity Surgery Registry

Investigators

  • Study Chair: Ingemar Näslund, Scandinavian Obesity Surgery Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2007

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimated)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Comorb

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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