The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies

Diabetes Clinical Trial

Official title:

The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173934
• Other study ID #: KY20230915-11
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Yong Luo
• Phone: +86 18951670850
• Email: luoyong132270[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 2, 3 years
Secondary	The blood glucose	According to the speed of gastric emptying, the time of insulin injection during meals is adjusted to observe MBG	1, 2, 3 years