DiabetesNCT06173934
The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies
A study testing insulin injection 15 minutes before meals and Insulin injection 15 minutes after eating in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Establish a cohort study to describe the characteristics of gastric emptying in patients with type 1 diabetes, and adjust the timing of insulin injection during meals to improve blood glucose fluctuations according to the speed of gastric emptying. Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- insulin injection 15 minutes before meals and Insulin injection 15 minutes after eating
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1.Volunteer and sign subject informed consent prior to the trial.
- 2.Patients with type 1 diabetes, aged less than 70 years, 7%≤HbA1c≤9.0%.
- 3.There were no acute complications such as diabetic ketoacidosis and diabetic hypertonic syndrome.
- 4.Subjects were able and willing to undergo 14-day scanning blood glucose monitoring, diet and exercise routine.
Who cannot join
- 1.Patients with severe gastrointestinal symptoms, history of gastrointestinal disease, surgical history, or impaired liver and kidney function.
- 2.Patients who have used drugs that affect gastrointestinal function or appetite in the last week.
- 3.History of drug abuse and alcohol dependence within the past 5 years.
- 4.Systemic hormone therapy was used in the last three months.
- 5.Patients with poor compliance, irregular diet and exercise.
- 6.Patients with infection and stress within four weeks.
Show all 9Show fewer
- 7.Patients who could not tolerate 14-day scanning blood glucose monitoring.
- 8.Patients who are pregnant, nursing or intending to become pregnant.
- 9.Any other obvious condition or comorbidities determined by the investigator: such as serious cardiopulmonary disease, endocrine disease, neurological, neoplastic, other pancreatic disease, history of mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu
Jianhua Ma, Professor
About this study
Establish a cohort study to describe the characteristics of gastric emptying in patients with type 1 diabetes, and adjust the timing of insulin injection during meals to improve blood glucose fluctuations according to the speed of gastric emptying.
Read the detailed description
- T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.
- T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.
- On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;
- Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.
- FGM monitoring was completed on the 14th day and the study was concluded. 2. On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;
- Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.
- FGM monitoring was completed on the 14th day and the study was concluded.
- Conditions
- Diabetes
- Being tested
- insulin injection 15 minutes before meals, Insulin injection 15 minutes after eating
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin injection 15 minutes before mealsDrug
Also called insulin regulation
Adjust insulin injection time to observe blood glucose spectrum
Insulin injection 15 minutes after eatingDrug
Also called insulin regulation
Adjust insulin injection time to observe blood glucose spectrum
| Study group | Role | What they receive |
|---|---|---|
| Patients with rapid gastric emptying | Experimental | Patients with rapid gastric emptying Receives: Drug: insulin injection 15 minutes before meals |
| Patients with slow gastric emptying | Experimental | Patients with slow gastric emptying Receives: Drug: Insulin injection 15 minutes after eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of gastric emptying(the gastric half-emptying time ) in patients with type 1 diabetes.
Correlation of gastric emptying with disease course, blood glucose fluctuation and complications.
Measured: 1, 2, 3 years
Secondary outcomes (1)
The blood glucose
According to the speed of gastric emptying, the time of insulin injection during meals is adjusted to observe MBG
Measured: 1, 2, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Principal investigator, Nanjing Medical University affiliated Nanjing First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173934
- Sponsor's protocol ID
- KY20230915-11
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT06173934
- Acronym / sponsor ID
- KY20230915-11
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 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.
Establish a cohort study to describe the characteristics of gastric emptying in patients with type 1 diabetes, and adjust the timing of insulin injection during meals to improve blood glucose fluctuations according to the speed of gastric emptying.
Detailed description
- T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.
- T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.
- On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;
- Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.
- FGM monitoring was completed on the 14th day and the study was concluded. 2. On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;
- Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.
- FGM monitoring was completed on the 14th day and the study was concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rapid gastric emptying | Experimental | Drug: insulin injection 15 minutes before mealsPatients with rapid gastric emptying |
| Patients with slow gastric emptying | Experimental | Drug: Insulin injection 15 minutes after eatingPatients with slow gastric emptying |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Volunteer and sign subject informed consent prior to the trial.
- 2.Patients with type 1 diabetes, aged less than 70 years, 7%≤HbA1c≤9.0%.
- 3.There were no acute complications such as diabetic ketoacidosis and diabetic hypertonic syndrome.
- 4.Subjects were able and willing to undergo 14-day scanning blood glucose monitoring, diet and exercise routine.
Key exclusion criteria (9 listed)
- 1.Patients with severe gastrointestinal symptoms, history of gastrointestinal disease, surgical history, or impaired liver and kidney function.
- 2.Patients who have used drugs that affect gastrointestinal function or appetite in the last week.
- 3.History of drug abuse and alcohol dependence within the past 5 years.
- 4.Systemic hormone therapy was used in the last three months.
- 5.Patients with poor compliance, irregular diet and exercise.
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 |
|---|---|---|
| insulin injection 15 minutes before mealsAlso: insulin regulationAdjust insulin injection time to observe blood glucose spectrum | Drug | Patients with rapid gastric emptying |
| Insulin injection 15 minutes after eatingAlso: insulin regulationAdjust insulin injection time to observe blood glucose spectrum | Drug | Patients with slow gastric emptying |
Primary outcome
Characteristics of gastric emptying(the gastric half-emptying time ) in patients with type 1 diabetes.
Time frame: 1, 2, 3 years
Correlation of gastric emptying with disease course, blood glucose fluctuation and complications.
1 secondary outcome
The blood glucose
Time frame: 1, 2, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
Jianhua Ma principal investigator
Nanjing Medical University affiliated Nanjing First 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 insulin injection 15 minutes before meals and Insulin injection 15 minutes after eating in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University 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 9 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Luo (+86 18951670850, luoyong132270@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of gastric emptying(the gastric half-emptying time ) in patients with type 1 diabetes. (time frame: 1, 2, 3 years). 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 18 Dec 2023.