Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.
The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.
This study is designed to mitigate the effects of glucose with intermittent oral Canagliflozin for healthy, non-diabetic volunteers of any sex who enroll in the study. Participants will provide informed consent via AgelessRx electronic medical record. If eligible, prescriptions will be provided online through the AgelessRx website (www.agelessrx.com). Participants will be randomized into two arms: Arm A will take 100 mg of canagliflozin each day for a total of 7 doses, while Arm B will take 150 mg of canagliflozin every other day for a total of 4 doses. Participants in Arm B will also be provided a pill cutter to use throughout the trial on the 300mg tablet.
All participants will begin the trial on the day that they apply a continuous glucose monitor (considered Day 0) and will be asked to take daily blood pressure reading. After one week of baseline readings, both arms will start their canagliflozin dosing protocols.
Participants will be asked to complete 7 total surveys to outline side effects and tolerability, one each day starting after their canagliflozin consumption.
Participants will be asked to complete a dietary intake journal through Day 0 -Day 14. Lifesum (https://lifesum.com/) should be used to track Carbohydrate/Protein/Fat consumption. Participants will share their dietary intake journal twice over their participation (Day 7 & Day 14).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100mg | Active Comparator | Participants assigned to this arm will be taking 100mg daily, up to 7 times, for study duration. |
|
| 150mg | Experimental | Participants assigned to this arm will be taking 150mg, every other day, up to 4 times, for study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invokana Pill | Drug | 100 mg and 150 mg doses, taken every day and every-other day, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose values after taking Canagliflozin | The primary endpoint, average glucose, will be assessed by examining blood glucose (mg/dL) area under curve as measured by CGM. Glucose data on days without Canagliflozin treatment will serve as a control. | 2- weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related side effects through collected survey responses | The secondary endpoints of safety and tolerability and urinary glucose excretion will also be assessed. Safety and tolerability will be measured by adverse event reporting, blood pressure monitoring, and by comparing treatment tolerability survey results with control tolerability results through subjective surveys. Urinary glucose excretion will be measured by at-home glucose testing strips. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James P Faber | Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM) | Study Chair |
| Sajad Zalzala, MD | AgelessRx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AgelessRx | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19502543 | Background | Lin HJ, Lee BC, Ho YL, Lin YH, Chen CY, Hsu HC, Lin MS, Chien KL, Chen MF. Postprandial glucose improves the risk prediction of cardiovascular death beyond the metabolic syndrome in the nondiabetic population. Diabetes Care. 2009 Sep;32(9):1721-6. doi: 10.2337/dc08-2337. Epub 2009 Jun 5. | |
| 25205142 | Background |
| Label | URL |
|---|---|
| Gottfried, Sara MD, "8 Reason Why Glucose is Worth Measuring." Metabolic Basics. June 17, 2022 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 24, 2024 | Feb 21, 2024 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2-weeks |
| Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9. |
| 26301188 | Background | Suh S, Kim JH. Glycemic Variability: How Do We Measure It and Why Is It Important? Diabetes Metab J. 2015 Aug;39(4):273-82. doi: 10.4093/dmj.2015.39.4.273. |
| 28217522 | Result | Prasanna Kumar KM, Ghosh S, Canovatchel W, Garodia N, Rajashekar S. A review of clinical efficacy and safety of canagliflozin 300 mg in the management of patients with type 2 diabetes mellitus. Indian J Endocrinol Metab. 2017 Jan-Feb;21(1):196-209. doi: 10.4103/2230-8210.196016. |
| 16508776 | Result | Papanikolaou Y, Palmer H, Binns MA, Jenkins DJ, Greenwood CE. Better cognitive performance following a low-glycaemic-index compared with a high-glycaemic-index carbohydrate meal in adults with type 2 diabetes. Diabetologia. 2006 May;49(5):855-62. doi: 10.1007/s00125-006-0183-x. Epub 2006 Mar 1. |
| Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, et al. (2018) Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol 16(7): e2005143 | View source |
| (2022), Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the | View source |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |