Type 2 DiabetesNCT05284344
The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Adelaide at 1 site in China.
Trial summary
Gastric emptying is now recognized as a major determinant of the blood glucose response to carbohydrate in both health and type 2 diabetes (T2D). While patients with longstanding diabetes exhibit a high prevalence of delayed gastric emptying, i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Anti-Diabetics
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2021to 31 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Han Chinese patients newly diagnosed type 2 diabetes Han Chinese non-diabetic subjects
Who may be able to join
- Patients newly diagnosed of type 2 diabetes as defined by published Criteria of World Health Organization in 1999; with HbA1c ≥ 7%, age ≥ 18 years of age and ≤ 80 years old, and willing to receive anti-diabetic treatments,
- Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes
Who cannot join
- Patients with a fasting blood glucose ≤ 3.9mmol/L;
- Patients with insulin allergy;
- Patients with severe gastrointestinal symptoms and diseases;
- Patients with gastrointestinal surgery history;
- Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin);
- Patients with major cardiovascular disease event (e.g., stroke, symptomatic peripheral artery disease, myocardial infarction, percutaneous coronary or peripheral artery angioplasty or coronary artery bypass surgery) in the previous 6 months;
Show all 10Show fewer
- Patients with liver dysfunction (aspartate aminotransferase or alanine aminotransferase level of more than two times the upper limit of normal range) or renal dysfunction (creatinine > 150 μmol/L or GFR < 60 mL/min/1.73m2);
- Patients with severe anemia and hemoglobin disorders (Hb < 60 g/L);
- Patients with infected injection site or coagulation disorders;
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Gastric emptying is now recognized as a major determinant of the blood glucose response to carbohydrate in both health and type 2 diabetes (T2D). While patients with longstanding diabetes exhibit a high prevalence of delayed gastric emptying, i.e. gastroparesis, patients with fewer complications are often associated with accelerated gastric emptying, which exacerbates postprandial glycaemic excursions. Moreover, gastric emptying appears to be more rapid in Han Chinese patients with T2D, as compared to Caucasian patients with T2D.
The proposed study will (i) compare the rate of gastric emptying in newly diagnosed, Chinese patients with T2D to non-diabetic controls, (ii) evaluate the relationship between gastric emptying and glycaemic indices, including measures of glucose variability, and (iii) determine whether gastric emptying is altered by glucose-lowering therapies.
Read the detailed description
A total of 100 newly diagnosed Han Chinese patients with type 2 diabetes will be recruited into the study through the Department of Endocrinology, Nanjing first Hospital. Following enrolment, patients will receive either an intensive insulin pump therapy for a months, or a combination of oral glucose-lowering agents (including metformin, DPP-4 inhibitors and/or sodium-glucose co-transporter-2 inhibitors), or a combination of oral glucose-lowering agents and injectable glucagon-like peptide-1 (GLP-1) receptor agonists for 3 months. Before the commencement of the therapy and on days 30 and 90, patients will attend the hospital for continuous glucose monitoring over 24 hours and measurement of gastric emptying using a 75 g oral glucose tolerance test (OGTT).
During their hospital stay, patients will consume 3 standard meals (i.e. breakfast, lunch and dinner) provided by the Department of Clinical Nutrition, with their glucose levels tracked by continuous glucose monitoring system (CGMS). Following the dinner, subjects will be asked to fast from solids and liquids (other than water) until the following morning, when they will be subjected to an OGTT at ~0900h. An intravenous cannula will be placed into a vein on the forearm. Subjects will be asked to consume a glucose drink containing 75 g glucose and 150mg 13C-acetate, within 5 min for the assessment of gastric emptying, postprandial glycemic and hormonal responses. Breath samples will be collected immediately before, and every 15 minutes after the drink for 3 hours for the measurement of gastric emptying. Venous blood samples will be taken at t = 0, 30, 60, 90, 120, 150 and 180 min for the measurements of plasma glucose, serum insulin, C-peptide, glucagon, total GLP-1, GIP and bile acids concentrations. Blood pressure and heart rate will be measured before and every 15 min after the drink for 3 hours.
- Conditions
- Type 2 Diabetes
- Being tested
- Anti-Diabetics
- Keywords
- type 2 diabetes, gastric emptying, gut hormones, blood glucose, bile acid, glycaemia variability
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-DiabeticsDrug
The anti-diabetic treatments include insulin glargine, insulin aspart, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor, metformin, sulfonylureas and/or gliclazide. Therapeutic dose of each drug follows recommendation by the treating doctor.
| Study group | Role | What they receive |
|---|---|---|
| patients with newly diagnosed type 2 diabetes | Newly diagnosed, drug-naïve, Chinese patients with type 2 diabetes. Receives: Drug: Anti-Diabetics | |
| Non-diabetic control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastric-half emptying time of the 75 g glucose drink
The Change in gastric-half emptying time (min) before and after the treatment
Measured: Baseline, 1 month and 3 months in diabetic group
Gastric-half emptying time of the 75 g glucose drink
The difference in gastric-half emptying time (min) between subjects with and without type 2 diabetes
Measured: Baseline in both diabetic and non-diabetic group
Secondary outcomes (11)
The mean blood glucose level
The mean blood glucose level (mmol/L) during the 24 hours continuous glucose monitoring.
Measured: Baseline, 1 month and 3 months in the diabetic group
The mean amplitude of glycemic excursion
The mean amplitude of glycemic excursion (mmol/L) during the 24 hours continuous glucose monitoring.
Measured: Baseline, 1 month and 3 months in the diabetic group
The percentage of blood glucose levels within the target range
The percentage of blood glucose levels within the target range (%) during the 24 hours continuous glucose monitoring.
Measured: Baseline, 1 month and 3 months in the diabetic group
Serum insulin concentrations
The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum insulin (mU/L) in response to a 75 g glucose drink before and after the treatment.
The incremental area under the curve (iAUC) is calculated using the trapezoidal rule.
Measured: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum C-peptide concentrations
The differences in the incremental area under the curve from 0 to 180 min (iAUC0-180min) for serum C-peptide (ng/mL) in response to a 75 g glucose drink before and after the treatment.
Measured: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum total GLP-1 concentrations
The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum total GLP-1 (pmol/L) in response to a 75 g glucose drink before and after the treatment.
Measured: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum total GIP concentrations
The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum total GIP (pmol/L) in response to a 75 g glucose drink before and after the treatment.
Measured: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum bile acid concentrations
The differences in the fasting serum bile acid concentrations (μmol/L) before and after the treatment.
Measured: Baseline, 1 month and 3 months in the diabetic group
Systolic blood pressure
The differences in systolic blood pressure (mmHg) in response to the 75 g glucose drink before and after the treatment.
Measured: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Diastolic blood pressure
The differences in diastolic blood pressure (mmHg) in response to the 75 g glucose drink before and after the treatment.
Measured: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Heart rate
The differences in heart rate (beats/min) in response to the 75 g glucose drink before and after the treatment.
Measured: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start24 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongzhi Wu, University of Adelaide
- Investigators
- Tongzhi Wu, PhD, Principal investigator, The University of AdelaideJianhua Ma, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284344
- Sponsor's protocol ID
- KY20220214-08
- Status last verified
- May 2024
- First submitted
- 24 Feb 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethical statement and informed consent do not allow for free data availability.
Publications
Xie C, Huang W, Wang X, Trahair LG, Pham HT, Marathe CS, Young RL, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric emptying in health and type 2 diabetes: An evaluation using a 75 g oral glucose drink. Diabetes Res Clin Pract. 2021 Jan;171:108610. doi: 10.1016/j.diabres.2020.108610. Epub 2020 Dec 7.
PubMed 33301790Wang X, Xie C, Marathe CS, Malbert CH, Horowitz M, Jones KL, Rayner CK, Sun Z, Wu T. Disparities in gastric emptying and postprandial glycaemia between Han Chinese and Caucasians with type 2 diabetes. Diabetes Res Clin Pract. 2020 Jan;159:107951. doi: 10.1016/j.diabres.2019.107951. Epub 2019 Nov 29.
PubMed 31790715Goyal RK. Gastric Emptying Abnormalities in Diabetes Mellitus. N Engl J Med. 2021 May 6;384(18):1742-1751. doi: 10.1056/NEJMra2020927. No abstract available.
PubMed 33951363Watson LE, Xie C, Wang X, Li Z, Phillips LK, Sun Z, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric Emptying in Patients With Well-Controlled Type 2 Diabetes Compared With Young and Older Control Subjects Without Diabetes. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3311-3319. doi: 10.1210/jc.2018-02736.
PubMed 30933282Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25.
PubMed 25421372Sun Y, Luo Y, Xiang C, Xie C, Huang W, Sun Z, Jones KL, Horowitz M, Rayner CK, Ma J, Wu T. Gastric emptying in newly diagnosed, treatment-naive Han Chinese with type 2 diabetes and the impact of 4-week insulin pump therapy. Diabetes Obes Metab. 2024 Aug;26(8):3078-3087. doi: 10.1111/dom.15626. Epub 2024 May 2.
PubMed 38698647
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05284344
- Acronym / sponsor ID
- KY20220214-08
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, gastric emptying, gut hormones, blood glucose, bile acid, glycaemia variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric emptying is now recognized as a major determinant of the blood glucose response to carbohydrate in both health and type 2 diabetes (T2D). While patients with longstanding diabetes exhibit a high prevalence of delayed gastric emptying, i.e. gastroparesis, patients with fewer complications are often associated with accelerated gastric emptying, which exacerbates postprandial glycaemic excursions. Moreover, gastric emptying appears to be more rapid in Han Chinese patients with T2D, as compared to Caucasian patients with T2D.
The proposed study will (i) compare the rate of gastric emptying in newly diagnosed, Chinese patients with T2D to non-diabetic controls, (ii) evaluate the relationship between gastric emptying and glycaemic indices, including measures of glucose variability, and (iii) determine whether gastric emptying is altered by glucose-lowering therapies.
Detailed description
A total of 100 newly diagnosed Han Chinese patients with type 2 diabetes will be recruited into the study through the Department of Endocrinology, Nanjing first Hospital. Following enrolment, patients will receive either an intensive insulin pump therapy for a months, or a combination of oral glucose-lowering agents (including metformin, DPP-4 inhibitors and/or sodium-glucose co-transporter-2 inhibitors), or a combination of oral glucose-lowering agents and injectable glucagon-like peptide-1 (GLP-1) receptor agonists for 3 months. Before the commencement of the therapy and on days 30 and 90, patients will attend the hospital for continuous glucose monitoring over 24 hours and measurement of gastric emptying using a 75 g oral glucose tolerance test (OGTT).
During their hospital stay, patients will consume 3 standard meals (i.e. breakfast, lunch and dinner) provided by the Department of Clinical Nutrition, with their glucose levels tracked by continuous glucose monitoring system (CGMS). Following the dinner, subjects will be asked to fast from solids and liquids (other than water) until the following morning, when they will be subjected to an OGTT at ~0900h. An intravenous cannula will be placed into a vein on the forearm. Subjects will be asked to consume a glucose drink containing 75 g glucose and 150mg 13C-acetate, within 5 min for the assessment of gastric emptying, postprandial glycemic and hormonal responses. Breath samples will be collected immediately before, and every 15 minutes after the drink for 3 hours for the measurement of gastric emptying. Venous blood samples will be taken at t = 0, 30, 60, 90, 120, 150 and 180 min for the measurements of plasma glucose, serum insulin, C-peptide, glucagon, total GLP-1, GIP and bile acids concentrations. Blood pressure and heart rate will be measured before and every 15 min after the drink for 3 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with newly diagnosed type 2 diabetes | – | Drug: Anti-DiabeticsNewly diagnosed, drug-naïve, Chinese patients with type 2 diabetes. |
| Non-diabetic control subjects | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Han Chinese patients newly diagnosed type 2 diabetes Han Chinese non-diabetic subjects
Key inclusion criteria (2 listed)
- Patients newly diagnosed of type 2 diabetes as defined by published Criteria of World Health Organization in 1999; with HbA1c ≥ 7%, age ≥ 18 years of age and ≤ 80 years old, and willing to receive anti-diabetic treatments,
- Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes
Key exclusion criteria (10 listed)
- Patients with a fasting blood glucose ≤ 3.9mmol/L;
- Patients with insulin allergy;
- Patients with severe gastrointestinal symptoms and diseases;
- Patients with gastrointestinal surgery history;
- Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin);
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 |
|---|---|---|
| Anti-DiabeticsThe anti-diabetic treatments include insulin glargine, insulin aspart, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor, metformin, sulfonylureas and/or gliclazide. Therapeutic dose of each drug follows recommendation by the treating doctor. | Drug | patients with newly diagnosed type 2 diabetes |
Primary outcome
Change in Gastric-half emptying time of the 75 g glucose drink
Time frame: Baseline, 1 month and 3 months in diabetic group
The Change in gastric-half emptying time (min) before and after the treatment
Gastric-half emptying time of the 75 g glucose drink
Time frame: Baseline in both diabetic and non-diabetic group
The difference in gastric-half emptying time (min) between subjects with and without type 2 diabetes
11 secondary outcomes
The mean blood glucose level
Time frame: Baseline, 1 month and 3 months in the diabetic group
The mean amplitude of glycemic excursion
Time frame: Baseline, 1 month and 3 months in the diabetic group
The percentage of blood glucose levels within the target range
Time frame: Baseline, 1 month and 3 months in the diabetic group
Serum insulin concentrations
Time frame: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum C-peptide concentrations
Time frame: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum total GLP-1 concentrations
Time frame: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum total GIP concentrations
Time frame: t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Serum bile acid concentrations
Time frame: Baseline, 1 month and 3 months in the diabetic group
Systolic blood pressure
Time frame: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Diastolic blood pressure
Time frame: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
Heart rate
Time frame: t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group
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 9 May 2024.
- Background: PubMed 33301790Xie C, Huang W, Wang X, Trahair LG, Pham HT, Marathe CS, Young RL, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric emptying in health and type 2 diabetes: An evaluation using a 75 g oral glucose drink. Diabetes Res Clin Pract. 2021 Jan;171:108610. doi: 10.1016/j.diabres.2020.108610. Epub 2020 Dec 7.
- Background: PubMed 31790715Wang X, Xie C, Marathe CS, Malbert CH, Horowitz M, Jones KL, Rayner CK, Sun Z, Wu T. Disparities in gastric emptying and postprandial glycaemia between Han Chinese and Caucasians with type 2 diabetes. Diabetes Res Clin Pract. 2020 Jan;159:107951. doi: 10.1016/j.diabres.2019.107951. Epub 2019 Nov 29.
- Background: PubMed 33951363Goyal RK. Gastric Emptying Abnormalities in Diabetes Mellitus. N Engl J Med. 2021 May 6;384(18):1742-1751. doi: 10.1056/NEJMra2020927. No abstract available.
- Background: PubMed 30933282Watson LE, Xie C, Wang X, Li Z, Phillips LK, Sun Z, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric Emptying in Patients With Well-Controlled Type 2 Diabetes Compared With Young and Older Control Subjects Without Diabetes. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3311-3319. doi: 10.1210/jc.2018-02736.
- Background: PubMed 25421372Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25.
- Derived from this study: PubMed 38698647Sun Y, Luo Y, Xiang C, Xie C, Huang W, Sun Z, Jones KL, Horowitz M, Rayner CK, Ma J, Wu T. Gastric emptying in newly diagnosed, treatment-naive Han Chinese with type 2 diabetes and the impact of 4-week insulin pump therapy. Diabetes Obes Metab. 2024 Aug;26(8):3078-3087. doi: 10.1111/dom.15626. Epub 2024 May 2.
- Individual participant dataSharing planned: No. The ethical statement and informed consent do not allow for free data availability.
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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.
Tongzhi Wu, PhD principal investigator
The University of Adelaide
Jianhua Ma, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical 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 Type 2 Diabetes, run by University of Adelaide 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 2 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 9 May 2024. 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?
Change in Gastric-half emptying time of the 75 g glucose drink (time frame: Baseline, 1 month and 3 months in diabetic group). The study lists 2 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 NCT05284344, which also lists 6 linked publications.
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 9 May 2024.