Obesity, MorbidNCT07919054
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
An observational study of Obesity, Morbid and Postmenopause, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Obesity changes how the body produces and processes estrogen. After menopause, higher estrogen exposure is linked to thickening of the lining of the womb (endometrium) and a higher risk of endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Morbid, Postmenopause, Endometrial Thickening
- What is being tested?
- Bariatric surgery and Conventional non-surgical obesity management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2026to 30 Apr 2028
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with obesity who meet the eligibility criteria for bariatric surgery, recruited from the General Surgery and Gynaecology outpatient clinics of Cairo University hospitals (Kasr Al Ainy). Women scheduled for bariatric surgery form the surgical cohort; women who meet the same criteria but choose non-surgical medical or lifestyle management form the comparison cohort, matched by age (within 5 years) and BMI class.
Who may be able to join
- Naturally postmenopausal women with more than 12 months of amenorrhea.
- Intact uterus.
- Obesity with full eligibility for bariatric surgery according to standard clinical guidelines (BMI 40 kg/m² or more, or BMI 35 kg/m² or more with obesity-related comorbidities).
- Surgical group: scheduled to undergo sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass.
- Non-surgical group: intending to follow non-surgical medical or lifestyle obesity management.
- Able and willing to undergo serial transvaginal ultrasound and blood sampling at baseline, 6 months and 12 months.
Who cannot join
- Known endometrial carcinoma or atypical endometrial hyperplasia requiring immediate oncological treatment.
- Previous hysterectomy.
- Major uterine pathology preventing reliable measurement of endometrial thickness (e.g., large submucosal fibroids).
- Current use of hormone replacement therapy, selective estrogen receptor modulators or other hormonal treatments expected to substantially alter endometrial thickness or estradiol levels.
- Inability, medical contraindication or refusal to undergo serial transvaginal ultrasound.
- Failure to complete the 12-month follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Changes in Serum Estradiol Levels and Endometrial Thickness Following Bariatric Surgery in Postmenopausal Women With Obesity: a Prospective Longitudinal Study
Obesity changes how the body produces and processes estrogen. After menopause, higher estrogen exposure is linked to thickening of the lining of the womb (endometrium) and a higher risk of endometrial cancer. Bariatric (weight-loss) surgery produces large and lasting weight loss, but how it changes estradiol levels and the endometrium in postmenopausal women is not well described.
This prospective cohort study will follow 78 postmenopausal women with obesity who are eligible for bariatric surgery at Cairo University hospitals: 39 women who undergo bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of their routine care, and 39 matched women who choose non-surgical medical and lifestyle management. Serum estradiol and endometrial thickness (measured by transvaginal ultrasound) will be measured at baseline and again 6 and 12 months later. The study will compare these changes between the two groups and examine whether changes in estradiol are associated with changes in endometrial thickness and with weight loss.
Read the detailed description
Background:
Obesity is associated with hormonal, metabolic and reproductive abnormalities that may influence endometrial proliferation. Increased adipose tissue is associated with altered estrogen metabolism, insulin resistance and other metabolic disturbances that may contribute to an increased risk of endometrial hyperplasia and endometrial cancer. Bariatric surgery is an established treatment for severe obesity and improves several metabolic and reproductive abnormalities, and published evidence suggests that it may alter reproductive hormone profiles and is associated with a lower long-term risk of obesity-related endometrial cancer. Transvaginal ultrasound is a non-invasive method for measuring endometrial thickness. In this study, endometrial thickness is used as a measurable marker of endometrial change, not as a screening test for endometrial cancer.
Objective:
To prospectively assess the effect of bariatric surgery on endometrial thickness and serum estradiol level in postmenopausal women with obesity, and to study the association between changes in serum estradiol and changes in endometrial thickness.
Design:
Prospective comparative cohort study at Cairo University hospitals (Kasr Al Ainy). Postmenopausal women presenting to the General Surgery and Gynaecology outpatient clinics are screened against the eligibility criteria and allocated to one of two parallel groups according to their planned clinical management:
- Bariatric surgery group (n = 39): scheduled for elective sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass. The choice of procedure is made by the surgical team as part of routine care; the study does not interfere with surgical decision-making. The procedure performed is documented.
- Non-surgical group (n = 39): women who meet the same eligibility criteria for bariatric surgery but choose conventional non-surgical medical or lifestyle management (standard dietary counselling and structured lifestyle modification supervised by their primary care physicians), matched to the surgical group by baseline age (within 5 years) and BMI class.
Baseline assessment (before surgery or before starting non-surgical management):
- Demographic, anthropometric, reproductive and clinical data: age, weight, height, waist circumference, BMI, parity, diabetes mellitus, hypertension, dyslipidaemia and current medications.
- Standard baseline investigations: complete blood count, INR, kidney and liver function tests, serum cortisol, HbA1c, thyroid function tests, ECG, echocardiography, upper gastrointestinal endoscopy and pelviabdominal ultrasound.
- Serum estradiol from a venous blood sample drawn under standardized conditions.
- Transvaginal ultrasound by a qualified investigator: endometrial thickness (mm) measured in the sagittal plane at the point of maximum thickness using a standardized technique, with scanning of the uterus and adnexa to document any structural abnormality.
Follow-up:
Both groups are reassessed at 6 and 12 months after baseline (after surgery in the surgical group) with the same protocol: weight, BMI and percentage of excess weight loss; serum estradiol; transvaginal endometrial thickness using the same technique; and documentation of any significant clinical events or complications.
Sample size:
Calculated with the ClinCalc sample size calculator for cohort studies (alpha 0.05, power 80%) from published serum estradiol values in women with obesity before and after bariatric surgery: 78 women in total (39 per group). Participants are enrolled by convenience sampling, with each surgical participant matched to a non-surgical control.
Statistical analysis:
SPSS version 25. Qualitative data are presented as number and percentage, and quantitative data as mean and standard deviation or median and interquartile range. Groups are compared with the chi-square or Fisher exact test for categorical data and the Student t test or paired t test for parametric data, with non-parametric equivalents where appropriate. Correlations are assessed with Pearson or Spearman coefficients as appropriate. A p value of 0.05 or less is considered significant.
Funding: Faculty of Medicine, Cairo University.
- Conditions
- Obesity, Morbid, Postmenopause, Endometrial Thickening
- Being tested
- Bariatric surgery, Conventional non-surgical obesity management
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Roux-en-Y gastric bypass, One-anastomosis gastric bypass, Estradiol, Endometrial thickness, Transvaginal ultrasound, Postmenopausal women
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called Metabolic and bariatric surgery
Elective sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass performed as part of routine clinical care. The procedure is chosen by the primary surgical team; the study protocol does not determine or influence the choice. The procedure performed is documented.
Conventional non-surgical obesity managementBehavioural
Routine conservative medical management of obesity consisting of standard dietary counselling and structured lifestyle modification supervised by the participant's primary care physician, without surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery group | Postmenopausal women with obesity scheduled for elective bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of routine care at Cairo University hospitals. Serum estradiol and transvaginal endometrial thickness are measured before surgery and 6 and 12 months after surgery. Planned n = 39. Receives: Procedure: Bariatric surgery | |
| Non-surgical management group | Postmenopausal women with obesity who meet the same eligibility criteria for bariatric surgery but choose conventional non-surgical medical or lifestyle management, matched to the surgical group by baseline age (within 5 years) and BMI class. Serum estradiol and transvaginal endometrial thickness are measured at baseline and 6 and 12 months later. Planned n = 39. Receives: Behavioral: Conventional non-surgical obesity management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum estradiol level from baseline to 12 months, compared between the surgical and non-surgical groups
Serum estradiol (pg/mL) measured in a venous blood sample drawn under standardized conditions at baseline (before surgery in the surgical group, before starting non-surgical management in the comparison group) and at 12 months. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Measured: Baseline and 12 months
Change in endometrial thickness from baseline to 12 months, compared between the surgical and non-surgical groups
Endometrial thickness (mm) measured by transvaginal ultrasound in the sagittal plane at the point of maximum thickness, using the same standardized technique at each visit. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Measured: Baseline and 12 months
Correlation between the change in serum estradiol level and the change in endometrial thickness
Correlation coefficient (Pearson or Spearman, as appropriate) between the 12-month change in serum estradiol (pg/mL) and the 12-month change in transvaginal endometrial thickness (mm) across both study groups.
Measured: Baseline to 12 months
Secondary outcomes (3)
Percentage of excess weight loss (%EWL)
Weight lost since baseline divided by baseline excess weight, multiplied by 100, recorded at 6 and 12 months in both groups.
Measured: 6 and 12 months
Correlation between change in BMI and serum estradiol level
Correlation coefficient (Pearson or Spearman, as appropriate) between the change in BMI (kg/m²) from baseline and serum estradiol (pg/mL) at 6 and 12 months, across both groups.
Measured: 6 and 12 months
Correlation between change in BMI and endometrial thickness
Correlation coefficient (Pearson or Spearman, as appropriate) between the change in BMI (kg/m²) from baseline and transvaginal endometrial thickness (mm) at 6 and 12 months, across both groups.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Cairo University
- Investigators
- Ahmed Mohamed Abdelsalam, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919054
- Sponsor's protocol ID
- MD-BS-E2-ET-2026
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Changes in Serum Estradiol Levels and Endometrial Thickness Following Bariatric Surgery in Postmenopausal Women With Obesity: a Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT07919054
- Acronym / sponsor ID
- MD-BS-E2-ET-2026
- Conditions
- Obesity, Morbid, Postmenopause, Endometrial Thickening
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Roux-en-Y gastric bypass, One-anastomosis gastric bypass, Estradiol, Endometrial thickness, Transvaginal ultrasound, Postmenopausal women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 5 Nov 2026 (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 changes how the body produces and processes estrogen. After menopause, higher estrogen exposure is linked to thickening of the lining of the womb (endometrium) and a higher risk of endometrial cancer. Bariatric (weight-loss) surgery produces large and lasting weight loss, but how it changes estradiol levels and the endometrium in postmenopausal women is not well described.
This prospective cohort study will follow 78 postmenopausal women with obesity who are eligible for bariatric surgery at Cairo University hospitals: 39 women who undergo bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of their routine care, and 39 matched women who choose non-surgical medical and lifestyle management. Serum estradiol and endometrial thickness (measured by transvaginal ultrasound) will be measured at baseline and again 6 and 12 months later. The study will compare these changes between the two groups and examine whether changes in estradiol are associated with changes in endometrial thickness and with weight loss.
Detailed description
Background:
Obesity is associated with hormonal, metabolic and reproductive abnormalities that may influence endometrial proliferation. Increased adipose tissue is associated with altered estrogen metabolism, insulin resistance and other metabolic disturbances that may contribute to an increased risk of endometrial hyperplasia and endometrial cancer. Bariatric surgery is an established treatment for severe obesity and improves several metabolic and reproductive abnormalities, and published evidence suggests that it may alter reproductive hormone profiles and is associated with a lower long-term risk of obesity-related endometrial cancer. Transvaginal ultrasound is a non-invasive method for measuring endometrial thickness. In this study, endometrial thickness is used as a measurable marker of endometrial change, not as a screening test for endometrial cancer.
Objective:
To prospectively assess the effect of bariatric surgery on endometrial thickness and serum estradiol level in postmenopausal women with obesity, and to study the association between changes in serum estradiol and changes in endometrial thickness.
Design:
Prospective comparative cohort study at Cairo University hospitals (Kasr Al Ainy). Postmenopausal women presenting to the General Surgery and Gynaecology outpatient clinics are screened against the eligibility criteria and allocated to one of two parallel groups according to their planned clinical management:
- Bariatric surgery group (n = 39): scheduled for elective sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass. The choice of procedure is made by the surgical team as part of routine care; the study does not interfere with surgical decision-making. The procedure performed is documented.
- Non-surgical group (n = 39): women who meet the same eligibility criteria for bariatric surgery but choose conventional non-surgical medical or lifestyle management (standard dietary counselling and structured lifestyle modification supervised by their primary care physicians), matched to the surgical group by baseline age (within 5 years) and BMI class.
Baseline assessment (before surgery or before starting non-surgical management):
- Demographic, anthropometric, reproductive and clinical data: age, weight, height, waist circumference, BMI, parity, diabetes mellitus, hypertension, dyslipidaemia and current medications.
- Standard baseline investigations: complete blood count, INR, kidney and liver function tests, serum cortisol, HbA1c, thyroid function tests, ECG, echocardiography, upper gastrointestinal endoscopy and pelviabdominal ultrasound.
- Serum estradiol from a venous blood sample drawn under standardized conditions.
- Transvaginal ultrasound by a qualified investigator: endometrial thickness (mm) measured in the sagittal plane at the point of maximum thickness using a standardized technique, with scanning of the uterus and adnexa to document any structural abnormality.
Follow-up:
Both groups are reassessed at 6 and 12 months after baseline (after surgery in the surgical group) with the same protocol: weight, BMI and percentage of excess weight loss; serum estradiol; transvaginal endometrial thickness using the same technique; and documentation of any significant clinical events or complications.
Sample size:
Calculated with the ClinCalc sample size calculator for cohort studies (alpha 0.05, power 80%) from published serum estradiol values in women with obesity before and after bariatric surgery: 78 women in total (39 per group). Participants are enrolled by convenience sampling, with each surgical participant matched to a non-surgical control.
Statistical analysis:
SPSS version 25. Qualitative data are presented as number and percentage, and quantitative data as mean and standard deviation or median and interquartile range. Groups are compared with the chi-square or Fisher exact test for categorical data and the Student t test or paired t test for parametric data, with non-parametric equivalents where appropriate. Correlations are assessed with Pearson or Spearman coefficients as appropriate. A p value of 0.05 or less is considered significant.
Funding: Faculty of Medicine, Cairo University.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery group | – | Procedure: Bariatric surgeryPostmenopausal women with obesity scheduled for elective bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of routine care at Cairo University hospitals. Serum estradiol and transvaginal endometrial thickness are measured before surgery and 6 and 12 months after surgery. Planned n = 39. |
| Non-surgical management group | – | Behavioral: Conventional non-surgical obesity managementPostmenopausal women with obesity who meet the same eligibility criteria for bariatric surgery but choose conventional non-surgical medical or lifestyle management, matched to the surgical group by baseline age (within 5 years) and BMI class. Serum estradiol and transvaginal endometrial thickness are measured at baseline and 6 and 12 months later. Planned n = 39. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with obesity who meet the eligibility criteria for bariatric surgery, recruited from the General Surgery and Gynaecology outpatient clinics of Cairo University hospitals (Kasr Al Ainy). Women scheduled for bariatric surgery form the surgical cohort; women who meet the same criteria but choose non-surgical medical or lifestyle management form the comparison cohort, matched by age (within 5 years) and BMI class.
Key inclusion criteria (6 listed)
- Naturally postmenopausal women with more than 12 months of amenorrhea.
- Intact uterus.
- Obesity with full eligibility for bariatric surgery according to standard clinical guidelines (BMI 40 kg/m² or more, or BMI 35 kg/m² or more with obesity-related comorbidities).
- Surgical group: scheduled to undergo sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass.
- Non-surgical group: intending to follow non-surgical medical or lifestyle obesity management.
Key exclusion criteria (6 listed)
- Known endometrial carcinoma or atypical endometrial hyperplasia requiring immediate oncological treatment.
- Previous hysterectomy.
- Major uterine pathology preventing reliable measurement of endometrial thickness (e.g., large submucosal fibroids).
- Current use of hormone replacement therapy, selective estrogen receptor modulators or other hormonal treatments expected to substantially alter endometrial thickness or estradiol levels.
- Inability, medical contraindication or refusal to undergo serial transvaginal ultrasound.
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 surgeryAlso: Metabolic and bariatric surgeryElective sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass performed as part of routine clinical care. The procedure is chosen by the primary surgical team; the study protocol does not determine or influence the choice. The procedure performed is documented. | Procedure or surgery | Bariatric surgery group |
| Conventional non-surgical obesity managementRoutine conservative medical management of obesity consisting of standard dietary counselling and structured lifestyle modification supervised by the participant's primary care physician, without surgery. | Behavioural | Non-surgical management group |
Primary outcome
Change in serum estradiol level from baseline to 12 months, compared between the surgical and non-surgical groups
Time frame: Baseline and 12 months
Serum estradiol (pg/mL) measured in a venous blood sample drawn under standardized conditions at baseline (before surgery in the surgical group, before starting non-surgical management in the comparison group) and at 12 months. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Change in endometrial thickness from baseline to 12 months, compared between the surgical and non-surgical groups
Time frame: Baseline and 12 months
Endometrial thickness (mm) measured by transvaginal ultrasound in the sagittal plane at the point of maximum thickness, using the same standardized technique at each visit. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Correlation between the change in serum estradiol level and the change in endometrial thickness
Time frame: Baseline to 12 months
Correlation coefficient (Pearson or Spearman, as appropriate) between the 12-month change in serum estradiol (pg/mL) and the 12-month change in transvaginal endometrial thickness (mm) across both study groups.
3 secondary outcomes
Percentage of excess weight loss (%EWL)
Time frame: 6 and 12 months
Correlation between change in BMI and serum estradiol level
Time frame: 6 and 12 months
Correlation between change in BMI and endometrial thickness
Time frame: 6 and 12 months
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 5 Nov 2026.
- 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.
Ahmed Mohamed Abdelsalam, MD principal investigator
Cairo University
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, Morbid and Postmenopause, run by Kasr El Aini Hospital 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 6 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
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?
Contact Fatima Abdelhady (+201092011196, fatima.a.abdelhady@students.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum estradiol level from baseline to 12 months, compared between the surgical and non-surgical groups (time frame: Baseline and 12 months). The study lists 3 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 5 Nov 2026.