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
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
Treatments tested in this trial
- Lactobacillus paracasei LC19 Intervention
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov