Obesity65plusNCT06081413
Bariatric and Metabolic Surgery in Patients Over 65 Years of Age
An observational study of Obesity and Diabetes Mellitus, Type 2, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial summary
A retrospective multicenter study that will analyze the results of surgical treatment of obesity in patients over 65 years of age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 284 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 31 Dec 2022
- 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 65 years and older
- All sexes
- Older adult
Study population: all patients over 65 years of age who underwent bariatric procedures
Who may be able to join
- 65 years of age and more
- undergone bariatric surgery
Who cannot join
- lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bariatric and Metabolic Surgery in Patients Over 65 Years of Age - a Multicenter Study
A retrospective multicenter study that will analyze the results of surgical treatment of obesity in patients over 65 years of age.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Hypertension
- Being tested
- bariatric surgery
- Keywords
- bariatric surgery, elderly patients, obesity-related diseases
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
bariatric surgeries - sleeve gastrectomy, roux-en-Y gastric bypass, one anastomosis gastric bypass, adjustable gastric band
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss after bariatric surgery
how much weight patients lost, determined by BMI
Measured: until December 31, 2022
improvement in obesity-related diseases
changes in the treatment of hypertension and diabetes type 2 - whether the diseases resolved completely or whether there was a change in medications (in accordance with the guidelines of the American Society for Metabolic and Bariatric Surgery ASMBS)
Measured: until December 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081413
- Sponsor's protocol ID
- 38/2023
- Acronym
- 65plus
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric and Metabolic Surgery in Patients Over 65 Years of Age - a Multicenter Study
- ClinicalTrials.gov ID
- NCT06081413
- Acronym / sponsor ID
- 65plus / 38/2023
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Hypertension
- Keywords
- bariatric surgery, elderly patients, obesity-related diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Oct 2023 (actual)
- 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.
A retrospective multicenter study that will analyze the results of surgical treatment of obesity in patients over 65 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- all patients over 65 years of age who underwent bariatric procedures
Key inclusion criteria (2 listed)
- 65 years of age and more
- undergone bariatric surgery
Key exclusion criteria (1 listed)
- lost to follow up
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 surgerybariatric surgeries - sleeve gastrectomy, roux-en-Y gastric bypass, one anastomosis gastric bypass, adjustable gastric band | Procedure or surgery | – |
Primary outcome
weight loss after bariatric surgery
Time frame: until December 31, 2022
how much weight patients lost, determined by BMI
improvement in obesity-related diseases
Time frame: until December 31, 2022
changes in the treatment of hypertension and diabetes type 2 - whether the diseases resolved completely or whether there was a change in medications (in accordance with the guidelines of the American Society for Metabolic and Bariatric Surgery ASMBS)
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 13 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Diabetes Mellitus, Type 2, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
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 2 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: finished, as of the sponsor's last update on 13 Oct 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 Poland. 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?
weight loss after bariatric surgery (time frame: until December 31, 2022). 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?
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 13 Oct 2023.