Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes.

NCT06440486 | Not Yet Recruiting

• 1 other identifier: WK2024008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers

  Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients.

  12 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.

Dietary Supplement: Probiotics

Maltodextrin

PLACEBO COMPARATOR

Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Serum and fecal samples were collected at the beginning and end of the study to evaluate the effects of probiotic consumption on immune markers, metabolites, and gut microbiota before and after administration.

Maltodextrin; Probiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
• Age 18 (inclusive) and above, gender not limited;
• Diagnosed with type 2 diabetes mellitus;
• Not diagnosed with cardiovascular, kidney, or any other diabetic complications.

You may not qualify if:

• Age over 75 years old;
• Use of exogenous insulin or patients with cardiovascular disease and other complications;
• Patients who are currently using α-glucosidase inhibitors;
• Patients who have a habit of taking probiotics or are currently taking probiotics;
• Pregnant or lactating women;
• Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Kang Liu, Doctor

CONTACT

15808432375; liukang@nsmc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: June 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: December 15, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)