Severe ObesityNCT02710786
Comorbidity After Gastric Bypass
An observational study of Severe Obesity, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 25,000 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Jan 2025
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals undergoing gastric bypass
Who may be able to join
- Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass
Who cannot join
- All other operations
Trial locations and contacts
1 site in 1 country.
Erik Näslund contact
Magnus Sundbom contact
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, 751 85
Magnus Sundbom, magnus.sundbom@surgsci.uu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Obesity
- Being tested
- Gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Gastric bypass surgery, i.e., small gastric pouch and excluded main stomach
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Patients undergoing gastric bypass Receives: Procedure: Gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (3)
Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions)
Glucose, HbA1c, LDL, HDL, triglycerides, and blood pressure
Measured: 10 years
Weight loss
Peroperative weight (in kg) minus current weight (in kg)
Measured: 10 years
BMI loss
Peroperative BMI minus current BMI. Weight and height will be combined to report BMI in kg/m^2.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2007
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, The Scandinavian Obesity Surgery Registry
- Responsible party
- Sponsor
- Investigators
- Ingemar Näslund, Study chair, Scandinavian Obesity Surgery Registry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710786
- Sponsor's protocol ID
- Comorb
- Status last verified
- Dec 2023
- First submitted
- 18 Feb 2016
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Resolution of Comorbidites After Gastric Bypass
- ClinicalTrials.gov ID
- NCT02710786
- Acronym / sponsor ID
- Comorb
- Conditions
- Severe Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, The Scandinavian Obesity Surgery Registry
- Study start
- May 2007 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 17 Mar 2016 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | – | Procedure: Gastric bypassPatients undergoing gastric bypass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals undergoing gastric bypass
Key inclusion criteria (1 listed)
- Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass
Key exclusion criteria (1 listed)
- All other operations
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 |
|---|---|---|
| Gastric bypassGastric bypass surgery, i.e., small gastric pouch and excluded main stomach | Procedure or surgery | Gastric bypass |
Primary outcome
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.
3 secondary outcomes
Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions)
Time frame: 10 years
Weight loss
Time frame: 10 years
BMI loss
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- 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.
Erik Näslund contact
Magnus Sundbom contact
Ingemar Näslund study chair
Scandinavian Obesity Surgery Registry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Dec 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Näslund (erik.naslund@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in comorbid conditions, as defined by use of pharmacological treatment (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2023.