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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus paracasei LC19 supplementation | Experimental |
| |
| Placebo probiotic milk powder | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change | Changes in HbA1c from baseline at12 weeks during follow-up | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose change | Changes in fasting blood glucose from baseline at 4, 8, and 12 weeks during follow-up | From baseline at 4, 8, and 12 weeks during follow-up |
| Glycated albumin change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Liu, MD | Contact | 010-85231710 | liujia0116@126.com | |
| Xiaoyu Ding, MD | Contact | 010-85231711 | dxycy0828@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guang Wang, MD | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-yang Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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). |
|
Changes in glycated albumin from baseline at 4 and 12 weeks during follow-up
| From baseline at 4 and 12 weeks during follow-up |
| Glycemic achieving rate | Glycemic achieving rate with HbA1c<6.5% at 12-week follow-up | From enrollment to the end of treatment at 12 weeks |
| Glucose tolerance | Changes in blood glucose levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up | From baseline at 4 and 12 weeks during follow-up |
| Insulin change | Changes in insulin levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up | From baseline at 4 and 12 weeks during follow-up |
| Plasma GLP-1 change | Changes in GLP-1 levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up | From baseline at 4 and 12 weeks during follow-up |
| BMI change | Changes in BMI from baseline at 4, 8, and 12 weeks during follow-up | From baseline at 4, 8, and 12 weeks during follow-up |
| Alteration of fecal metabolites | Fecal metabolites analysis from baseline to 12-week follow-up | From enrollment to the end of treatment at 12 weeks |
| Alteration of gut microbiome | Fecal metagenomics sequencing from baseline to 12-week follow-up | From enrollment to the end of treatment at 12 weeks |
| D004700 | Endocrine System Diseases |