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

Type 2 Diabetes Clinical Trial

Official title:

Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440486
• Other study ID #: WK2024008
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: Kang Liu, Doctor
• Phone: 15808432375
• Email: liukang[@]nsmc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;

2. Age 18 (inclusive) and above, gender not limited;

3. Diagnosed with type 2 diabetes mellitus;

4. Not diagnosed with cardiovascular, kidney, or any other diabetic complications.

Exclusion Criteria:

1. Age over 75 years old;

2. Use of exogenous insulin or patients with cardiovascular disease and other complications;

3. Patients who are currently using a-glucosidase inhibitors;

4. Patients who have a habit of taking probiotics or are currently taking probiotics;

5. Pregnant or lactating women;

6. Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Probiotics
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.

Locations

Country	Name	City	State
China	Nanchong Central Hospital	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-a), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1ß, and interferon-gamma (IFN-?) to assess the impact of probiotics on T2DM patients.	12 weeks