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Participants will receive prednisone 40 mg for 3 days. 75 g oral glucose tolerance test (OGTT), insulin and C-peptide will be measured on day 1 (before prednisone) and day 3 (after prednisone). Also capillary glucose values will be obtained during and after the period of prednisone intake.
On their scheduled day, participants will be instructed to come to the clinic after an overnight fast of a minimum of 8 hours (subjects can drink water). The participants will be asked to refrain from drinking alcohol for a period of 24 hours before the study days and to not perform strenuous exercise for a period of 48 hours before the study days. The participants will be directed to avoid alcohol and strenuous exercise for the duration of the study.
On days 1 and 3 of the study period, participants will be checked into the clinic. A physical examination, including height, weight and waist circumference, and finger-stick glucose will be performed. A 75-g OGTT will be performed with venous samples for measurement of glucose, insulin and C-peptide levels obtained at 0, 30 and 60 minutes starting immediately after the ingestion of the 75 g glucose solution. After samples are collected on day 1, participants will be administered their first dose of steroid, prednisone 40 mg, and be given a packet of two additional doses for the rest of the study period. The investigators may only give 1 additional dose to them and have the participants take the last dose in clinic on day 3 two hours before the OGTT. Subjects will take prednisone 40 mg once daily for three days to be consumed around 8:00am on days 2 and 3. This dose was chosen as a typical high-dose glucocorticoid regimen. On the third day, the participants will again visit the clinic after an overnight fast of a minimum 8 hours and undergo a physical examination and OGTT just as on day 1.
Participants will be instructed to check pre-prandial (before breakfast, lunch and dinner), and bed time (around 10:00 pm) blood glucose (BG) levels and to record all values for a total of five days (three days while on prednisone and for two days after the second study visit). A member of the study staff will call each participant daily around 7:00 pm to obtain BG values. Compliance with the study protocol will be assessed at this time as well. Any subject not compliant with study medications will be excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone in subjects with Diabetes | Experimental | Group of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days |
|
| Prednisone in control subjects | Experimental | Group of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 40 mg po q day of Prednisone for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC for glucose during OGTT | Comparison of the Area under the curve (AUC) of the OGTT for glucose values at 60 and 120 throughout the course of 3 days | Throughout the course of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA index | Comparison of Homeostatic model assessment (HOMA) index before and after receiving the prednisone dose (at day 1 and at day 3) | At day 1 and at day 3 |
| AUC for Insulin during OGTT | Comparison of the Area under the curve of the OGTT for glucose values at 60 and 120 minutes throughout the course of 3 days |
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Experimental Group
Inclusion Criteria:
Exclusion Criteria:
Control Group
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16901792 | Background | Donihi AC, Raval D, Saul M, Korytkowski MT, DeVita MA. Prevalence and predictors of corticosteroid-related hyperglycemia in hospitalized patients. Endocr Pract. 2006 Jul-Aug;12(4):358-62. doi: 10.4158/EP.12.4.358. | |
| 24123849 | Background | Hwang JL, Weiss RE. Steroid-induced diabetes: a clinical and molecular approach to understanding and treatment. Diabetes Metab Res Rev. 2014 Feb;30(2):96-102. doi: 10.1002/dmrr.2486. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol
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| Throughout the course of 3 days |
| 21562755 | Background | van Raalte DH, Brands M, van der Zijl NJ, Muskiet MH, Pouwels PJ, Ackermans MT, Sauerwein HP, Serlie MJ, Diamant M. Low-dose glucocorticoid treatment affects multiple aspects of intermediary metabolism in healthy humans: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):2103-12. doi: 10.1007/s00125-011-2174-9. Epub 2011 May 12. |
| 32369480 | Derived | Shah M, Adel MM, Tahsin B, Guerra Y, Fogelfeld L. Effect of short-term prednisone on beta-cell function in subjects with type 2 diabetes mellitus and healthy subjects. PLoS One. 2020 May 5;15(5):e0231190. doi: 10.1371/journal.pone.0231190. eCollection 2020. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |