Clinical trial NCT06639425: Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes
Official title: Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: In this trial, approximately 60 drug-naive patients with newly diagnosed Type 2 Diabetes (T2D) will be recruited. Laboratory evaluations will be conducted on the subjects to confirm their eligibility before randomization. After the screening, eligible subjects will be randomly assigned in a 1:1 ratio to either the Lactobacillus paracasei LC19 supplementation group or the placebo group during the randomization visit. They will then enter a 12-week double-blind treatment period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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\&amp;amp;amp;#39;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
* Subjects with history of chronic active hepatitis and/or severe liver dysfunction, renal dysfunction, and thyroid dysfunction
* Subjects with a medical history of malignant tumor
* Subjects with history of gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.) or with a history of intestinal resection or other gastrointestinal surgery (such as cholecystectomy) within one year before the screening period
* Subjects with history of surgery, or severe trauma in the past 6 months, or planning to undergo surgery during the study period
* Subjects suffering from severe infections, severe anemia, or neutropenia
* Subjects pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study period
* Subjects with history of receiving immunosuppressants, steroids, anti diarrheal drugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motility medications within the past 3 months;
* Subjects using other medications that can affect blood glucose in the past 3 months
* Subjects with consumption of other probiotic or prebiotic products in the past 3 months before secreening
* Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases
* Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period
* Subjects with history of mental illness or epilepsy, or taking antidepressant medications
* Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40 grams per day and for women, exceeding 20 grams per day)
* Subjects have participated in any other clinical study in the past 3 months

Primary outcomes:
measure: HbA1c change
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: fasting blood glucose change
timeFrame: From baseline at 4, 8, and 12 weeks during follow-up
measure: Glycated albumin change
timeFrame: From baseline at 4 and 12 weeks during follow-up
measure: Glycemic achieving rate
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Glucose tolerance
timeFrame: From baseline at 4 and 12 weeks during follow-up
measure: Insulin change
timeFrame: From baseline at 4 and 12 weeks during follow-up
measure: Plasma GLP-1 change
timeFrame: From baseline at 4 and 12 weeks during follow-up
measure: BMI change
timeFrame: From baseline at 4, 8, and 12 weeks during follow-up
measure: Alteration of fecal metabolites
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Alteration of gut microbiome
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Guang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: