HypertensionNCT04235829
Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes
An observational study of Hypertension and Diabetes Mellitus, Type 2, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2, Gastrostomy
- What is being tested?
- Laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2012to Jan 2019
- How long will I take part?
- 7 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients undergoing laparoscopic sleeve gastrectomy at a single center between April and October 2012
Who may be able to join
- LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
- Have not undergone any further bariatric surgical procedures since the index operation
- Still be alive at the time of the study
- Have correct be contactable with the contact details present available in the electronic database
Who cannot join
- Missing data
- Uncontactable
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter
A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.
Read the detailed description
Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.
Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.
Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.
- Being tested
- Laparoscopic sleeve gastrectomy
- Keywords
- sleeve gastrectomy, morbid obesity, predicting outcomes, early weight loss, hypertension, diabetes mellitus
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Obesity, Morbid, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Form of obesity surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between early % total weight loss and % total weight loss 7 years following surgery.
A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.
Measured: A comparison made between 4 weeks and 7 years following the index surgery.
Secondary outcomes (1)
Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..
Reduction / resolution of either hypertension or type 2 diabetes mellitus as defined by a reduction or cessation of medical treatment for the respective comorbidity. Patient diagnoses before surgery were compared with medical and medication histories taken at 7 years follow up.
Measured: A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Apr 2012
- Primary completion1 Oct 2012
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prospective
- Enrolment
- 156 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Tankel, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235829
- Sponsor's protocol ID
- SZMC-95/19
- Status last verified
- Jan 2020
- First submitted
- 30 Nov 2019
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter
- ClinicalTrials.gov ID
- NCT04235829
- Acronym / sponsor ID
- SZMC-95/19
- Keywords
- sleeve gastrectomy, morbid obesity, predicting outcomes, early weight loss, hypertension, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 1 Oct 2012 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jan 2020 (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 study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.
Detailed description
Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.
Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.
Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing laparoscopic sleeve gastrectomy at a single center between April and October 2012
Key inclusion criteria (4 listed)
- LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
- Have not undergone any further bariatric surgical procedures since the index operation
- Still be alive at the time of the study
- Have correct be contactable with the contact details present available in the electronic database
Key exclusion criteria (3 listed)
- Missing data
- Uncontactable
- Unwilling to participate
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomyForm of obesity surgery | Procedure or surgery | – |
Primary outcome
Correlation between early % total weight loss and % total weight loss 7 years following surgery.
Time frame: A comparison made between 4 weeks and 7 years following the index surgery.
A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.
1 secondary outcome
Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..
Time frame: A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.
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 22 Jan 2020.
- 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 Hypertension and Diabetes Mellitus, Type 2, run by Shaare Zedek Medical Center at 1 site in Israel.
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 4 inclusion and 3 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 22 Jan 2020. 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 Israel. 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?
Correlation between early % total weight loss and % total weight loss 7 years following surgery. (time frame: A comparison made between 4 weeks and 7 years following the index surgery.). 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 22 Jan 2020.