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This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.
In this study, the investigators seek to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans. Continuous glucose monitors (CGM) are minimally invasive devices that measure glucose levels in interstitial fluid. A small wire is inserted subcutaneously which transmits the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder. In usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify trends or look back over time (ie over night). In our study, the patient will be blinded to the data so as not to confound results, as it has been noted in another study that patient's blood sugar control was better when they were able to see CGM results and modified their diet. CGM's have been shown to have clinical accuracies of 95.5-98.9% and have been used in clinical trials and found to be safe. Having the patient do a finger-stick glucose intermittently during the time they are wearing the CGM improves accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAZ320 | Experimental | Patients will all take part in the control arm of the study and then be crossed over into treatment with PAZ320 at two different dosages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAZ320 | Drug | Single-center pilot study, open label dose escalation design |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura E Trask, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Jefferson | New Hampshire | 03755 | United States |
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| ID | Term |
|---|---|
| C000598421 | PAZ320 |
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