Obesity &Amp;Amp; OverweightNCT07188571
Observational Study on GER in Patients With Simple Obesity
An observational study of Obesity &Amp;Amp; Overweight and Gastric Emptying Time, run by Jing Ma at 1 site in China.
Trial summary
Dear Patients, The investigators invite participants to take part in an observational study on gastric emptying rate in individuals with simple obesity. This study has been reviewed and approved by the Ethics Committee of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity &Amp;Amp; Overweight, Gastric Emptying Time, Type2 Diabetes Mellitus
- What is being tested?
- Gastric emptying scintigraphy
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Aug 2025
- How long will I take part?
- 1 Year
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants included in the study were diagnosed with obesity, aged 18-65 years, without severe wasting diseases, who had not received medication affecting gastric motility, and who had no contraindications for gastric emptying scintigraphy or blood sampling.
Who may be able to join
- Diagnostic criteria for obesity (BMI ≥ 28 kg/m²) and/or waist circumference ≥ 90 cm in adult males, ≥ 85 cm in adult females, or waist-to-hip ratio ≥ 0.9 in males and ≥ 0.85 in females;
- Age 18-65 years;
- Consent to undergo venous blood sampling and gastric emptying scintigraphy, with no contraindications to these procedures;
- Consent to participate in this research project.
Who cannot join
- Diagnosed with secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc.;
- Severe cardiovascular or cerebrovascular disease, rheumatic or immune-mediated disorders;
- Severe metabolic disorders, such as diabetic ketoacidosis, hyperosmolar hyperglycaemic state, etc.;
- Advanced malignant tumours;
- History of medication known to affect glucose/lipid metabolism or gastric emptying rate, such as GLP-1 receptor agonists, glucocorticoids, antibiotics, anxiolytics or antidepressants;
- Pregnancy or lactation;
Show all 10Show fewer
- Severe bleeding tendency or inability to undergo venous blood sampling;
- Contraindications for gastric emptying scintigraphy, including pregnancy, lactation, severe gastrointestinal disorders such as acute gastrointestinal haemorrhage, intestinal obstruction or perforation, or allergy to components of the test meal;
- Patients refusing gastric emptying scintigraphy, or refusal to sign the informed consent form;
- Other circumstances deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Gastric Emptying Rate in Patients With Simple Obesity
Dear Patients, The investigators invite participants to take part in an observational study on gastric emptying rate in individuals with simple obesity. This study has been reviewed and approved by the Ethics Committee of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. It will be conducted at Renji Hospital and is expected to enroll approximately 100 voluntary participants.
Obesity has become a major global public health challenge. In 2020, an estimated 2.2 billion adults-42% of the global adult population-were affected by overweight and obesity. This number is projected to increase to 3.3 billion by 2035, representing 54% of adults worldwide. Obesity significantly compromises health and is associated with a range of metabolic disorders, including insulin resistance, atherogenic dyslipidemia (characterized by elevated triglycerides and low HDL cholesterol), nonalcoholic fatty liver disease (NAFLD), beta-cell dysfunction, prediabetes, and type 2 diabetes, all of which may lead to serious complications, disability, and premature death.
Read more
Gastric emptying refers to the process by which food moves from the stomach into the duodenum. This process is essential for nutrient absorption and is regulated by gastric motility, as well as by neural and hormonal feedback mechanisms mediated by the interaction of nutrients with the small intestine. The rate of gastric emptying determines the pace at which nutrients reach the intestine and influences the enteral nutrient load. It also plays a bidirectional role in regulating blood glucose levels. Therefore, abnormal gastrointestinal motility may represent an important pathophysiological mechanism underlying insulin resistance and impaired glucose tolerance in obese individuals.
To date, most studies on gastric emptying have focused on individuals with diabetes. However, as obesity itself is a major risk factor for metabolic diseases such as type 2 diabetes, further investigation into the distribution patterns of gastric emptying rates in individuals with simple obesity-and its associations with glucose and lipid metabolism, insulin resistance-could provide valuable insights. These insights may support improved diagnosis, risk stratification, and management of obesity-related metabolic disorders, as well as inform the evaluation of weight-loss interventions.
The aim of this study is to assess gastric emptying velocity in patients with simple obesity and to explore its relationship with glucose and lipid metabolic indicators.
This information sheet is intended to help participants decide whether they are willing to allow the use of their historical medical data for research and analysis. Participation in this study is entirely voluntary, and participants' decision will not affect their access to medical care or any of their rights as patients at Renji Hospital. Please be assured that, should participants choose to participate, the investigators will make every effort to protect their safety, privacy, and legal rights throughout the study, in full compliance with applicable ethical and legal standards.
The investigators kindly ask participants to read this notice carefully. If participants have any questions or concerns, they are encouraged to speak with the investigator responsible for explaining the informed consent form.
- Being tested
- Gastric emptying scintigraphy
- Keywords
- Observational Study
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying scintigraphyDiagnostic test
To assess gastric emptying rates in patients with simple obesity and diagnose the presence of gastric motility abnormalities.
| Study group | Role | What they receive |
|---|---|---|
| simple obesity | Inclusion criteria were: diagnosis of obesity (BMI ≥28 kg/m²) and/or waist circumference ≥90 cm in men or ≥85 cm in women, or waist-to-hip ratio ≥0.9 in men and ≥0.85 in women; age 18-65 years; willingness to undergo venous blood sampling and gastric emptying scintigraphy without contraindications; and provision of informed consent. Exclusion criteria included: secondary obesity (e.g., hypothyroidism, Cushing's syndrome, polycystic ovary syndrome); severe cardiovascular, cerebrovascular, autoimmune, or metabolic disease; advanced malignancy; history of drugs affecting glucose-lipid metabolism or gastric emptying; pregnancy or lactation; bleeding tendency; inability to complete venous sampling; contraindications to scintigraphy (such as acute gastrointestinal bleeding, obstruction, perforation, or allergy to test meal) ; refusal of required procedures or consent; and any condition deemed unsuitable. Receives: Diagnostic Test: Gastric emptying scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric half-emptying time
Gastric half-emptying time (T½) was used as a quantitative parameter to assess gastric emptying function. T½ was defined as the time required for 50% of the ingested standardized radiolabeled test meal to empty from the stomach. Measurement was performed by gastric emptying scintigraphy, during which serial anterior and posterior images were acquired to monitor the time-activity curve of gastric radioactivity. The half-emptying time was determined as the point at which gastric counts declined to 50% of baseline values. Prolongation of T½ is indicative of delayed gastric emptying, commonly observed in conditions such as diabetic gastroparesis or functional dyspepsia, whereas shortening of T½ suggests accelerated gastric emptying, which may occur in certain postoperative states or functional gastrointestinal disorders.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jul 2025
- Primary completion15 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp;Amp; OverweightStudies 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
- Cross-sectional
- Enrolment
- 163 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jing Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Ma, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188571
- Sponsor's protocol ID
- LY 2025-132-A-RE001
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Collaborators to be determined
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Gastric Emptying Rate in Patients With Simple Obesity
- ClinicalTrials.gov ID
- NCT07188571
- Acronym / sponsor ID
- LY 2025-132-A-RE001
- Keywords
- Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Jing MaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 23 Sep 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.
Dear Patients, The investigators invite participants to take part in an observational study on gastric emptying rate in individuals with simple obesity. This study has been reviewed and approved by the Ethics Committee of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. It will be conducted at Renji Hospital and is expected to enroll approximately 100 voluntary participants.
Obesity has become a major global public health challenge. In 2020, an estimated 2.2 billion adults-42% of the global adult population-were affected by overweight and obesity. This number is projected to increase to 3.3 billion by 2035, representing 54% of adults worldwide. Obesity significantly compromises health and is associated with a range of metabolic disorders, including insulin resistance, atherogenic dyslipidemia (characterized by elevated triglycerides and low HDL cholesterol), nonalcoholic fatty liver disease (NAFLD), beta-cell dysfunction, prediabetes, and type 2 diabetes, all of which may lead to serious complications, disability, and premature death.
Gastric emptying refers to the process by which food moves from the stomach into the duodenum. This process is essential for nutrient absorption and is regulated by gastric motility, as well as by neural and hormonal feedback mechanisms mediated by the interaction of nutrients with the small intestine. The rate of gastric emptying determines the pace at which nutrients reach the intestine and influences the enteral nutrient load. It also plays a bidirectional role in regulating blood glucose levels. Therefore, abnormal gastrointestinal motility may represent an important pathophysiological mechanism underlying insulin resistance and impaired glucose tolerance in obese individuals.
To date, most studies on gastric emptying have focused on individuals with diabetes. However, as obesity itself is a major risk factor for metabolic diseases such as type 2 diabetes, further investigation into the distribution patterns of gastric emptying rates in individuals with simple obesity-and its associations with glucose and lipid metabolism, insulin resistance-could provide valuable insights. These insights may support improved diagnosis, risk stratification, and management of obesity-related metabolic disorders, as well as inform the evaluation of weight-loss interventions.
The aim of this study is to assess gastric emptying velocity in patients with simple obesity and to explore its relationship with glucose and lipid metabolic indicators.
This information sheet is intended to help participants decide whether they are willing to allow the use of their historical medical data for research and analysis. Participation in this study is entirely voluntary, and participants' decision will not affect their access to medical care or any of their rights as patients at Renji Hospital. Please be assured that, should participants choose to participate, the investigators will make every effort to protect their safety, privacy, and legal rights throughout the study, in full compliance with applicable ethical and legal standards.
The investigators kindly ask participants to read this notice carefully. If participants have any questions or concerns, they are encouraged to speak with the investigator responsible for explaining the informed consent form.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| simple obesity | – | Diagnostic Test: Gastric emptying scintigraphyInclusion criteria were: diagnosis of obesity (BMI ≥28 kg/m²) and/or waist circumference ≥90 cm in men or ≥85 cm in women, or waist-to-hip ratio ≥0.9 in men and ≥0.85 in women; age 18-65 years; willingness to undergo venous blood sampling and gastric emptying scintigraphy without contraindications; and provision of informed consent. Exclusion criteria included: secondary obesity (e.g., hypothyroidism, Cushing's syndrome, polycystic ovary syndrome); severe cardiovascular, cerebrovascular, autoimmune, or metabolic disease; advanced malignancy; history of drugs affecting glucose-lipid metabolism or gastric emptying; pregnancy or lactation; bleeding tendency; inability to complete venous sampling; contraindications to scintigraphy (such as acute gastrointestinal bleeding, obstruction, perforation, or allergy to test meal) ; refusal of required procedures or consent; and any condition deemed unsuitable. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants included in the study were diagnosed with obesity, aged 18-65 years, without severe wasting diseases, who had not received medication affecting gastric motility, and who had no contraindications for gastric emptying scintigraphy or blood sampling.
Key inclusion criteria (4 listed)
- Diagnostic criteria for obesity (BMI ≥ 28 kg/m²) and/or waist circumference ≥ 90 cm in adult males, ≥ 85 cm in adult females, or waist-to-hip ratio ≥ 0.9 in males and ≥ 0.85 in females;
- Age 18-65 years;
- Consent to undergo venous blood sampling and gastric emptying scintigraphy, with no contraindications to these procedures;
- Consent to participate in this research project.
Key exclusion criteria (10 listed)
- Diagnosed with secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc.;
- Severe cardiovascular or cerebrovascular disease, rheumatic or immune-mediated disorders;
- Severe metabolic disorders, such as diabetic ketoacidosis, hyperosmolar hyperglycaemic state, etc.;
- Advanced malignant tumours;
- History of medication known to affect glucose/lipid metabolism or gastric emptying rate, such as GLP-1 receptor agonists, glucocorticoids, antibiotics, anxiolytics or antidepressants;
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 |
|---|---|---|
| Gastric emptying scintigraphyTo assess gastric emptying rates in patients with simple obesity and diagnose the presence of gastric motility abnormalities. | Diagnostic test | simple obesity |
Primary outcome
gastric half-emptying time
Time frame: Baseline
Gastric half-emptying time (T½) was used as a quantitative parameter to assess gastric emptying function. T½ was defined as the time required for 50% of the ingested standardized radiolabeled test meal to empty from the stomach. Measurement was performed by gastric emptying scintigraphy, during which serial anterior and posterior images were acquired to monitor the time-activity curve of gastric radioactivity. The half-emptying time was determined as the point at which gastric counts declined to 50% of baseline values. Prolongation of T½ is indicative of delayed gastric emptying, commonly observed in conditions such as diabetic gastroparesis or functional dyspepsia, whereas shortening of T½ suggests accelerated gastric emptying, which may occur in certain postoperative states or functional gastrointestinal disorders.
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 4 Mar 2026.
- Individual participant dataSharing planned: Undecided. Collaborators to be determined
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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 Obesity &Amp;Amp; Overweight and Gastric Emptying Time, run by Jing Ma 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 4 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 4 Mar 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 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?
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?
gastric half-emptying time (time frame: Baseline). 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 4 Mar 2026.