The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
- 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;
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yong Luo
- Phone Number: +86 18951670850
- Email: luoyong132270@sina.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Recruiting
- Nanjing First Hospital, Nanjing Medical University
-
Contact:
- Jianhua Ma, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with rapid gastric emptying
|
Adjust insulin injection time to observe blood glucose spectrum
Other Names:
|
|
Experimental: Patients with slow gastric emptying
|
Adjust insulin injection time to observe blood glucose spectrum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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, 2, 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The blood glucose
Time Frame: 1, 2, 3 years
|
According to the speed of gastric emptying, the time of insulin injection during meals is adjusted to observe MBG
|
1, 2, 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jianhua Ma, Nanjing Medical University affiliated Nanjing First Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20230915-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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