The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies
NCT ID: NCT06173934
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;
3. 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.
4. 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;
3\. 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.
4\. FGM monitoring was completed on the 14th day and the study was concluded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with rapid gastric emptying
Patients with rapid gastric emptying
insulin injection 15 minutes before meals
Adjust insulin injection time to observe blood glucose spectrum
Patients with slow gastric emptying
Patients with slow gastric emptying
Insulin injection 15 minutes after eating
Adjust insulin injection time to observe blood glucose spectrum
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin injection 15 minutes before meals
Adjust insulin injection time to observe blood glucose spectrum
Insulin injection 15 minutes after eating
Adjust insulin injection time to observe blood glucose spectrum
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
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.
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jianhua Ma
Role: PRINCIPAL_INVESTIGATOR
Nanjing Medical University affiliated Nanjing First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jianhua Ma, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KY20230915-11
Identifier Type: -
Identifier Source: org_study_id