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

December 15, 2023 updated by: Nanjing First Hospital, Nanjing Medical University
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.

Study Overview

Status

Recruiting

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.

  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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital, Nanjing Medical University
        • Contact:
          • Jianhua Ma, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: insulin injection 15 minutes before meals
Adjust insulin injection time to observe blood glucose spectrum
Other Names:
  • insulin regulation
Experimental: Patients with slow gastric emptying
Drug: Insulin injection 15 minutes after eating
Adjust insulin injection time to observe blood glucose spectrum
Other Names:
  • insulin regulation

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

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Jianhua Ma, Nanjing Medical University affiliated Nanjing First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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