Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

NCT06639425 | Recruiting

• 1 other identifier: 2024-DM-Lp
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c change

  Changes in HbA1c from baseline at12 weeks during follow-up

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (9)

• fasting blood glucose change

  From baseline at 4, 8, and 12 weeks during follow-up

• Glycated albumin change

  From baseline at 4 and 12 weeks during follow-up

• Glycemic achieving rate

  From enrollment to the end of treatment at 12 weeks

• Glucose tolerance

  From baseline at 4 and 12 weeks during follow-up

• Insulin change

  From baseline at 4 and 12 weeks during follow-up

Study Arms (2)

Lactobacillus paracasei LC19 supplementation

EXPERIMENTAL

Dietary Supplement: Lactobacillus paracasei LC19 supplementation

Placebo probiotic milk powder

PLACEBO COMPARATOR

Dietary Supplement: Placebo probiotic milk powder

Interventions

Lactobacillus paracasei LC19 supplementation DIETARY_SUPPLEMENT

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).

Lactobacillus paracasei LC19 supplementation

Placebo probiotic milk powder DIETARY_SUPPLEMENT

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).

Placebo probiotic milk powder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Guang Wang, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Liu, MD

CONTACT

010-85231710; liujia0116@126.com

Xiaoyu Ding, MD

CONTACT

010-85231711; dxycy0828@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 15, 2024
• Study Start: October 12, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (1)