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Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Chao Yang Hospital

About this trial

This is a single-arm study to investigate the heterogeneity of glycemic response to Lactobacillus paracasei LC19 in patients with newly diagnosed type 2 diabetes. Participants will receive LC19 for 12 weeks, and changes in glycemic control will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years, both genders eligible

Drug-naive patients with newly diagnosed type 2 diabetes

Subjects with screening HbA1c ≥ 7.0% and ≤ 9.0%

Subjects understand the nature, significance, potential benefits, inconvenience, and risks and procedure of the study, and voluntarily sign the informed consent form

Disqualifiers

Other types of diabetes except T2D: type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing's syndrome, etc.)

Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 6 months

Subjects with history of hypoglycemia in the past 6 months

Subjects with history of New York Heart Association class (NYHA) grade of heart function ≥ III or serious cardiovascular diseases (myocardial infarction, or with the history of cardiac interventional therapy or stent implantation, valve disease or valve repair, unstable angina, transient ischemic attack or stroke) within 6 months before the screening period

Trial design

Design model

Single group

Treatments tested in this trial

  • Lactobacillus paracasei LC19 Intervention

    Dietary supplement

    All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Lactobacillus paracasei LC19 supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c change

Changes in HbA1c from baseline to week 12 during follow-up

Time frame
12 weeks

Secondary outcomes

1

Glucose tolerance

Changes in blood glucose levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12

Time frame
12 weeks
2

Plasma GLP-1 change

Changes in GLP-1 levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12

Time frame
12 weeks
3

BMI change

Change in BMI from baseline to week 4, week 8, and week 12

Time frame
12 weeks
4

Weight change

Change in weight from baseline to week 4, week 8, and week 12

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Chao Yang Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: