Endometrium CancerNCT06169449
Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
A study testing Weight management--diet, Weight management--exercise and Weight management--accompany in people with Endometrium Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- Weight management--diet, Weight management--exercise and Weight management--accompany
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years old
- diagnosed as endometrial cancer or atypical hyperplasia
- immunohistochemical staining and sequencing of pathological tissue
- fertility-preserving therapy
- BMI≥25 kg/m2
- informed consent.
Who cannot join
- those with communication barriers
- pregnant women
- medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, China, 100044
Li, +8615010305099
About this study
In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
Read the detailed description
Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility-sparing treatment in endometrial cancer recommend weight management. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
- Conditions
- Endometrium Cancer
- Being tested
- Weight management--diet, Weight management--exercise, Weight management--accompany, Weight management--refresh, Control group
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight management--dietBehavioural
The diet structure adopts an energy-limited balanced diet. In this structure, the total daily energy intake is reduced by 500~1000 kcal based on the target energy intake; however, the balance is maintained for the energy supply ratio of the three major nutrients (with carbohydrate, protein, and fat accounting for 55~60%, 10~20%, and 15~30% of the total daily energy, respectively). Combined with the patient's eating habits, the food exchange portion method is used as a guide; each portion providing 90 kcal is considered as one portion. Specific recipes are formulated after calculating the ideal weight and the total daily calorie intake based on activity intensity, determining the number of six food exchange portions and the distribution of three meals according to the total calorie and diet structure, and combining the equivalent food exchange table based on individual tastes and preferences; this ensures patient acceptability and implementation.
Weight management--exerciseBehavioural
Exercise goals are divided into four levels based on individual health conditions and personal preferences; these include: cultivating exercise habits, improving cardiopulmonary function, enhancing muscle strength, and improving flexibility. Individualized exercise prescriptions that specify the exercise type, intensity, time, and frequency are formulated.
Weight management--accompanyBehavioural
This component involves the inclusion of patients in online management. Online groups are established, daily feedback is obtained regarding weight management implementation, self-sharing is encouraged, and peer support is established; a total of 6 sessions of online health education are provided once every 4 weeks for 20-60 minutes at each session. This includes information regarding the risks associated with overweightness and obesity; weight management benefits; knowledge regarding diet and nutrition, exercise and sports, and behavioral styles; and problem exchange and sharing, among others. Professional support is provided by weekly communication with patients one-on one via WeChat or telephonic conversations. The patient's diet and exercise record sheet are checked, patients are asked questions regarding implementation of the current program and any discomfort or difficulties; corresponding guidance is provided as appropriate.
Weight management--refreshBehavioural
According to the dietary nutrition guidelines for Chinese residents, patients are advised to drink 2500 ml or more of water daily; they are also advised to work and rest regularly to ensure sufficient sleep time, ensure smooth bowel movements, take deep breaths when waking up in the morning, pay attention to the work-rest balance, avoid being sedentary, and stand up and move around at least once every 50 minutes, maintain physical vitality by adjusting daily living habits.
Control groupBehavioural
The relationship between overweightness and obesity and endometrial cancer risk was explained to patients in the control group and their willingness for self-weight management was respected. Communication was maintained with patients from treatment initiation to 3 and 6 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.
| Study group | Role | What they receive |
|---|---|---|
| Weight management Group | Experimental | Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. Receives: Behavioral: Weight management--diet; Behavioral: Weight management--exercise; Behavioral: Weight management--accompany; Behavioral: Weight management--refresh |
| Control Group | Other | Patients in the control group underwent routine care for self-weight management. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index（BMI）--physiological parameter
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)"
Measured: 6 months of intervention
waist-to-height ratio (WHtR)--physiological parameter
Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
Measured: 6 months of intervention
waist-to-hip ratio (WHR)--physiological parameter
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
Measured: 6 months of intervention
body shape index (ABSI)--physiological parameter
Calculate ABSI according to the formula"ABSI= (waist)/([BMI]^2/3×height^1/2)"
Measured: 6 months of intervention
body roundness index (BRI)--physiological parameter
Calculate BRI according to the formula"BRI= waist/BMI"
Measured: 6 months of intervention
visceral fat index (VAI)--physiological parameter
Calculate VAI according to the formula"VAI= waist/(36.58 + 1.89 × BMI) × triglyceride (TG) level/0.81 × 1.52/high density lipoprotein (HDL) level"
Measured: 6 months of intervention
lipid accumulation index (LAP) (female)--physiological parameter
Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"
Measured: 6 months of intervention
waist circumference--physiological parameter
measured with the subject's body upright, abdomen relaxed, both arms hanging down naturally, feet together, and the tape measure placed around the waist; the height was adjusted to the horizontal plane passing through the midpoint of the line between the lower edge of the rib arch and the iliac crest in the mid-axillary line
Measured: 6 months of intervention
hip circumference--physiological parameter
measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip
Measured: 6 months of intervention
body fat mass (BFM)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Measured: 6 months of intervention
muscle mass--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Measured: 6 months of intervention
percent body fat (PBF)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Measured: 6 months of intervention
basal metabolic rate--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Measured: 6 months of intervention
visceral fat area (VFA)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Measured: 6 months of intervention
triglycerides--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
cholesterol--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
high density lipoprotein(HDL)--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
low density lipoprotein--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
fasting glucose--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
fasting insulin (FINS)--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
glycated hemoglobin--physiological parameter
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Measured: 6 months of intervention
homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter
Calculate HOMA-IR according to the formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"
Measured: 6 months of intervention
Secondary outcomes (3)
Complete remission
Complete remission indicated by complete endometrial regression and interstitial metaplasia-like changes on histopathology after treatment (without any endometrial atypical hyperplasia or endometrioid adenocarcinoma lesions, as clarified by pathologists)
Measured: 6 months of intervention
Recurrence
After complete remission, the reappearance of endometrioid adenocarcinoma or atypical endometrial hyperplasia during follow-up or after pregnancy or childbearing is defined as recurrence and is diagnosed by the pathologist.
Measured: 6 months of intervention
Pregnancy
The clinical diagnosis was pregnancy.
Measured: 2 years of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrium CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodan Li, Peking University People's Hospital
- Investigators
- Xiaodan Li, Master, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169449
- Sponsor's protocol ID
- RDL2022-49
- Status last verified
- Aug 2025
- First submitted
- 12 Nov 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Yang J, Wan Y, Li Q, Yang D, Wang Y, Gong J, Bai L, Liu Y, Li X, Wang J. DEAR model in overweight endometrial cancer patients undergoing fertility-sparing treatment: A randomized controlled trial. Gynecol Oncol. 2024 Jun;185:148-155. doi: 10.1016/j.ygyno.2024.02.017. Epub 2024 Feb 28.
PubMed 38422947
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
- ClinicalTrials.gov ID
- NCT06169449
- Acronym / sponsor ID
- RDL2022-49
- Conditions
- Endometrium Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Dec 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.
In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
Detailed description
Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility-sparing treatment in endometrial cancer recommend weight management. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight management Group | Experimental | Behavioral: Weight management--diet, Behavioral: Weight management--exercise, Behavioral: Weight management--accompany, Behavioral: Weight management--refreshPatients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. |
| Control Group | Other | Behavioral: Control groupPatients in the control group underwent routine care for self-weight management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 years old
- diagnosed as endometrial cancer or atypical hyperplasia
- immunohistochemical staining and sequencing of pathological tissue
- fertility-preserving therapy
- BMI≥25 kg/m2
Key exclusion criteria (3 listed)
- those with communication barriers
- pregnant women
- medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.
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 |
|---|---|---|
| Weight management--dietThe diet structure adopts an energy-limited balanced diet. In this structure, the total daily energy intake is reduced by 500~1000 kcal based on the target energy intake; however, the balance is maintained for the energy supply ratio of the three major nutrients (with carbohydrate, protein, and fat accounting for 55~60%, 10~20%, and 15~30% of the total daily energy, respectively). Combined with the patient's eating habits, the food exchange portion method is used as a guide; each portion providing 90 kcal is considered as one portion. Specific recipes are formulated after calculating the ideal weight and the total daily calorie intake based on activity intensity, determining the number of six food exchange portions and the distribution of three meals according to the total calorie and diet structure, and combining the equivalent food exchange table based on individual tastes and preferences; this ensures patient acceptability and implementation. | Behavioural | Weight management Group |
| Weight management--exerciseExercise goals are divided into four levels based on individual health conditions and personal preferences; these include: cultivating exercise habits, improving cardiopulmonary function, enhancing muscle strength, and improving flexibility. Individualized exercise prescriptions that specify the exercise type, intensity, time, and frequency are formulated. | Behavioural | Weight management Group |
| Weight management--accompanyThis component involves the inclusion of patients in online management. Online groups are established, daily feedback is obtained regarding weight management implementation, self-sharing is encouraged, and peer support is established; a total of 6 sessions of online health education are provided once every 4 weeks for 20-60 minutes at each session. This includes information regarding the risks associated with overweightness and obesity; weight management benefits; knowledge regarding diet and nutrition, exercise and sports, and behavioral styles; and problem exchange and sharing, among others. Professional support is provided by weekly communication with patients one-on one via WeChat or telephonic conversations. The patient's diet and exercise record sheet are checked, patients are asked questions regarding implementation of the current program and any discomfort or difficulties; corresponding guidance is provided as appropriate. | Behavioural | Weight management Group |
| Weight management--refreshAccording to the dietary nutrition guidelines for Chinese residents, patients are advised to drink 2500 ml or more of water daily; they are also advised to work and rest regularly to ensure sufficient sleep time, ensure smooth bowel movements, take deep breaths when waking up in the morning, pay attention to the work-rest balance, avoid being sedentary, and stand up and move around at least once every 50 minutes, maintain physical vitality by adjusting daily living habits. | Behavioural | Weight management Group |
| Control groupThe relationship between overweightness and obesity and endometrial cancer risk was explained to patients in the control group and their willingness for self-weight management was respected. Communication was maintained with patients from treatment initiation to 3 and 6 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management. | Behavioural | Control Group |
Primary outcome
Body Mass Index（BMI）--physiological parameter
Time frame: 6 months of intervention
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)"
waist-to-height ratio (WHtR)--physiological parameter
Time frame: 6 months of intervention
Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
waist-to-hip ratio (WHR)--physiological parameter
Time frame: 6 months of intervention
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
body shape index (ABSI)--physiological parameter
Time frame: 6 months of intervention
Calculate ABSI according to the formula"ABSI= (waist)/([BMI]^2/3×height^1/2)"
body roundness index (BRI)--physiological parameter
Time frame: 6 months of intervention
Calculate BRI according to the formula"BRI= waist/BMI"
visceral fat index (VAI)--physiological parameter
Time frame: 6 months of intervention
Calculate VAI according to the formula"VAI= waist/(36.58 + 1.89 × BMI) × triglyceride (TG) level/0.81 × 1.52/high density lipoprotein (HDL) level"
lipid accumulation index (LAP) (female)--physiological parameter
Time frame: 6 months of intervention
Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"
waist circumference--physiological parameter
Time frame: 6 months of intervention
measured with the subject's body upright, abdomen relaxed, both arms hanging down naturally, feet together, and the tape measure placed around the waist; the height was adjusted to the horizontal plane passing through the midpoint of the line between the lower edge of the rib arch and the iliac crest in the mid-axillary line
hip circumference--physiological parameter
Time frame: 6 months of intervention
measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip
body fat mass (BFM)--physiological parameter
Time frame: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
muscle mass--physiological parameter
Time frame: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
percent body fat (PBF)--physiological parameter
Time frame: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
basal metabolic rate--physiological parameter
Time frame: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
visceral fat area (VFA)--physiological parameter
Time frame: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
triglycerides--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
cholesterol--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
high density lipoprotein(HDL)--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
low density lipoprotein--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
fasting glucose--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
fasting insulin (FINS)--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
glycated hemoglobin--physiological parameter
Time frame: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter
Time frame: 6 months of intervention
Calculate HOMA-IR according to the formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"
3 secondary outcomes
Complete remission
Time frame: 6 months of intervention
Recurrence
Time frame: 6 months of intervention
Pregnancy
Time frame: 2 years of intervention
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 3 Sep 2025.
- Derived from this study: PubMed 38422947Chen Y, Yang J, Wan Y, Li Q, Yang D, Wang Y, Gong J, Bai L, Liu Y, Li X, Wang J. DEAR model in overweight endometrial cancer patients undergoing fertility-sparing treatment: A randomized controlled trial. Gynecol Oncol. 2024 Jun;185:148-155. doi: 10.1016/j.ygyno.2024.02.017. Epub 2024 Feb 28.
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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.
Xiaodan Li, Master study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management--diet, Weight management--exercise and Weight management--accompany in people with Endometrium Cancer, run by Peking University People's Hospital at 1 site in China.
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 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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 China. 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 Xiaodan Li, Master (+8615010305099, lxd_2000_510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index（BMI）--physiological parameter (time frame: 6 months of intervention). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169449, which also lists 1 linked publication.
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 3 Sep 2025.