Obesity and Obesity-related Medical ConditionsNCT06859320
Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression
A study testing laparoscopic sleeve gastrectomy in people with Obesity and Obesity-related Medical Conditions, run by Zagazig University at 2 sites in Egypt.
Trial summary
Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- 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
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy
Who cannot join
- patients less than 18 or above 60
- other psychiatric or medical disorders.
- patients not fit for surgery
- un controlled patients
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine
Zagazig, Sharqia Province, 44519
Zagazig University Hospitals
Zagazig, 44519
About this study
Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.
- Being tested
- laparoscopic sleeve gastrectomy
- Keywords
- obesity, hypothyroidism, Depression
- Medical subject headings
- Obesity, Hypothyroidism, Depression
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 sleeve gastrectomy is one of the popular bariatric surgeries known for weight reduction
| Study group | Role | What they receive |
|---|---|---|
| morbid obesity and overweight in patients with hypothyroidism and depression | Other | Not described Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid function tests
TSH,T3,T4 are measured pre and post operative
Measured: from one day to one year after surgery
depression
depression status is compared pre-operative and post-operative using depression questionnaire (PHQ-9)( patient health questionnaire-9)
Measured: from one day to one year after surgery
weight
weight of the patient will be measured in Kg using weight scale
Measured: from one day to one year after surgery
dose of thyroid replacement therapy
the dose of L-thyroxin is monitored in microgrames
Measured: monthly from one day to one year post surgery.
gasteric leakage
leakage after surgery from staple line measured in ml in the drain
Measured: from one day to 1 week post-surgery
wound infection
wound infection will be identified by pus in the drain or in the wound
Measured: from one day to 2 weeks post-surgery
Secondary outcomes (3)
age
age will be measured in years
Measured: 2 days pre-operative
sex
sex of patient (male or female) will be recorded before surgery
Measured: 2 days pre-operative
BMI ( Body Mass Index)
BMI is measured by the sum of weight in kg divided by the squared height in meters
Measured: 2 days before surgery to one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859320
- Sponsor's protocol ID
- #1108\25-Feb-2025
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression
- ClinicalTrials.gov ID
- NCT06859320
- Acronym / sponsor ID
- #1108\25-Feb-2025
- Keywords
- obesity, hypothyroidism, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| morbid obesity and overweight in patients with hypothyroidism and depression | Other | Procedure: laparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy
Key exclusion criteria (4 listed)
- patients less than 18 or above 60
- other psychiatric or medical disorders.
- patients not fit for surgery
- un controlled patients
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 sleeve gastrectomy is one of the popular bariatric surgeries known for weight reduction | Procedure or surgery | morbid obesity and overweight in patients with hypothyroidism and depression |
Primary outcome
thyroid function tests
Time frame: from one day to one year after surgery
TSH,T3,T4 are measured pre and post operative
depression
Time frame: from one day to one year after surgery
depression status is compared pre-operative and post-operative using depression questionnaire (PHQ-9)( patient health questionnaire-9)
weight
Time frame: from one day to one year after surgery
weight of the patient will be measured in Kg using weight scale
dose of thyroid replacement therapy
Time frame: monthly from one day to one year post surgery.
the dose of L-thyroxin is monitored in microgrames
gasteric leakage
Time frame: from one day to 1 week post-surgery
leakage after surgery from staple line measured in ml in the drain
wound infection
Time frame: from one day to 2 weeks post-surgery
wound infection will be identified by pus in the drain or in the wound
3 secondary outcomes
age
Time frame: 2 days pre-operative
sex
Time frame: 2 days pre-operative
BMI ( Body Mass Index)
Time frame: 2 days before surgery to one year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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.
2 sites 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 Obesity and Obesity-related Medical Conditions, run by Zagazig University at 2 sites 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
thyroid function tests (time frame: from one day to one year after surgery). The study lists 6 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 14 Aug 2025.