Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Official title

Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes

Overview

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.

Interventions

• Dietary supplement Lactobacillus paracasei LC19 supplementation
  Orally 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).
• Dietary supplement Placebo probiotic milk powder
  Orally 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).

Primary outcome measures

• HbA1c change [Time frame: From enrollment to the end of treatment at 12 weeks]

Secondary outcome measures (9)

• fasting blood glucose change [Time frame: From baseline at 4, 8, and 12 weeks during follow-up]
• Glycated albumin change [Time frame: From baseline at 4 and 12 weeks during follow-up]
• Glycemic achieving rate [Time frame: From enrollment to the end of treatment at 12 weeks]
• Glucose tolerance [Time frame: From baseline at 4 and 12 weeks during follow-up]
• Insulin change [Time frame: From baseline at 4 and 12 weeks during follow-up]
• Plasma GLP-1 change [Time frame: From baseline at 4 and 12 weeks during follow-up]
• BMI change [Time frame: From baseline at 4, 8, and 12 weeks during follow-up]
• Alteration of fecal metabolites [Time frame: From enrollment to the end of treatment at 12 weeks]
• Alteration of gut microbiome [Time frame: From enrollment to the end of treatment at 12 weeks]

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\'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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Chao-yang Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06639425 · 2024-DM-Lp

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗