Bariatric Surgery CandidateNCT05430932
Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels
A study testing Laparoscopic sleeve gastrectomy in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Vitamin D Deficiency
- What is being tested?
- Laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Dec 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult
- male or female
- from 18 to 60 ages
- BMI: 40 kg/m2 or > 35 kg/m2
- comorbidities e.g., hypertension and DM
- conservative management for obesity failed in at least 2 years
Who cannot join
- BMI > 60
- history of bariatric surgery
- symptomatic reflux oesophagitis
- stomach cancer
- active peptic ulcer disease
- alcohol or drug abuse
Show all 10Show fewer
- major psychological disturbance
- major eating troubles
- risky anesthesia
- risky surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
Official title: Effect Of Laparoscopic Sleeve Gastrectomy (LSG) on Vitamin D, Parathormone and Calcium Levels
Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades.
the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.
- Being tested
- Laparoscopic sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Laparoscopic resection of a part of the stomach to enable the patient to lose weight.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | After sleeve gastrectomy, assessment of vitamin D, calcium and parathormone levels is performed. Receives: Procedure: Laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level assessment
Assessment of the vitamin D level after sleeve gastrectomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Oct 2018
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aouf, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430932
- Sponsor's protocol ID
- MKSU50-5-24
- Status last verified
- Aug 2022
- First submitted
- 18 Jun 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Laparoscopic Sleeve Gastrectomy (LSG) on Vitamin D, Parathormone and Calcium Levels
- ClinicalTrials.gov ID
- NCT05430932
- Acronym / sponsor ID
- MKSU50-5-24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Jun 2022 (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.
Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades.
the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | Procedure: Laparoscopic sleeve gastrectomyAfter sleeve gastrectomy, assessment of vitamin D, calcium and parathormone levels is performed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult
- male or female
- from 18 to 60 ages
- BMI: 40 kg/m2 or > 35 kg/m2
- comorbidities e.g., hypertension and DM
Key exclusion criteria (10 listed)
- BMI > 60
- history of bariatric surgery
- symptomatic reflux oesophagitis
- stomach cancer
- active peptic ulcer disease
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 gastrectomyLaparoscopic resection of a part of the stomach to enable the patient to lose weight. | Procedure or surgery | Laparoscopic sleeve gastrectomy |
Primary outcome
Vitamin D level assessment
Time frame: 1 year
Assessment of the vitamin D level after sleeve gastrectomy.
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 5 Aug 2022.
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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?
A study testing Laparoscopic sleeve gastrectomy in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Kafrelsheikh University at 1 site in Egypt.
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 6 inclusion and 10 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 5 Aug 2022. 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 Egypt. 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?
Vitamin D level assessment (time frame: 1 year). 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 5 Aug 2022.