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The study was halted due to low enrollment exacerbated by COVID-19.
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The pilot study is designed to investigate the acute and chronic effects of the diet supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with type 2 diabetes mellitus.
This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial function.All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period. The study will consist of four visits (screening visit and three study visits), and last up to 2 weeks for individual subjects, depending on the time between visits. It is estimated that the study will last two years from IRB approval through data analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUDCA Group | Experimental | All subjects will receive 500 mg/day in a one week run-in period and then 1750 mg/day in one week treatment period of of the nutritional supplement Tauroursodeoxycholic acid (TUDCA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tauroursodeoxycholic acid | Dietary Supplement | Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular function | Endothelium -dependent flow-mediated dilation of the brachial artery by ultrasound and fingertip tonometry at baseline and 5-minute cuff occlusion of the upper arm. | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in endoplasmic reticulum stress | Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. ER stress will be measured by the study of early and chronic markers of ER stress activation by western blotting and PCR techniques. | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Hamburg, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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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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| ID | Term |
|---|---|
| C031655 | ursodoxicoltaurine |
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| Change in endothelial function | Endothelial cells will be collected utilizing a J-wire inserted into an arm vein with an 18 gauge catheter using sterile technique and local anesthesia. Endothelial function will be measured by the study of endothelial nitric oxide synthase activation and nitric oxide production | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
| Change in fasting glucose | The blood sample will be processed to measure fasting glucose levels | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
| Change in insulin levels | The blood sample will be processed to measure insulin levels | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
| Change in lipid levels | The blood sample will be processed to measure lipids levels including total cholesterol, LDL, HDL and triglycerides | before and 4 hours after TUDCA treatment at the screening and 3 study visits during a 2 week period |
| D004700 | Endocrine System Diseases |