Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Chao Yang Hospital
About this trial
This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Lactobacillus paracasei LC19 supplementation
Dietary supplementOrally administered Lactobacillus paracasei LC19 strain product, in addition to lifestyle intervention. This product is a probiotic milk powder, and the Lactobacillus paracasei LC19 strain is capable of producing high levels of tryptophan-conjugated cholic acid (Trp-CA)( 25g/packet, 2 packets/day).
Placebo probiotic milk powder
Dietary supplementOrally administered placebo probiotic milk powder, in addition to lifestyle intervention. The placebo probiotic strain also belongs to Lactobacillus paracasei species, but does not produce Trp-CA. These products have the same color, odor, appearance, and packaging (25g/packet, 2 packets/day).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Lactobacillus paracasei LC19 supplementationExperimental treatment 1 intervention
Group B: Placebo probiotic milk powderPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c change
Changes in HbA1c from baseline at12 weeks during follow-up
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
fasting blood glucose change
Changes in fasting blood glucose from baseline at 4, 8, and 12 weeks during follow-up
Time frame
From baseline at 4, 8, and 12 weeks during follow-up2
Glycated albumin change
Changes in glycated albumin from baseline at 4 and 12 weeks during follow-up
Time frame
From baseline at 4 and 12 weeks during follow-up3
Glycemic achieving rate
Glycemic achieving rate with HbA1c\<6.5% at 12-week follow-up
Time frame
From enrollment to the end of treatment at 12 weeks4
Glucose tolerance
Changes in blood glucose levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up
Time frame
From baseline at 4 and 12 weeks during follow-upSponsors and contacts
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Source ClinicalTrials.gov