Effect of Short Course of Glucocorticoid in Patients With Diabetes Mellitus(DM) Type 2
Primary Purpose
Diabetes, Hyperglycemia Steroid-induced
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes focused on measuring Diabetes, Glucocorticoids, Hyperglycemia
Eligibility Criteria
Experimental Group
Inclusion Criteria:
- Males or non-pregnant females between the ages of 18-50 years being followed in the Diabetes Center.
- Type 2 Diabetes for ≤ 1 year and only on metformin
- BMI 24.0-35.0 kg/ m2
- HBA1c ≤ 9.0%
Exclusion Criteria:
- Patients on any other antidiabetes medication.
- Patients with impaired renal function (estimated Glomerular Filtration Rate (GFR) less than 60 ml/min based on results from Cerner).
- Patient who have received glucocorticoid therapy within six months of study.
- Patients who do shift work.
- Blood glucose level ≥ 250 mg/dl on finger-stick at clinic visit.
- Signs or symptoms of infection.
Control Group
Inclusion Criteria:
- Males or non-pregnant females between the ages of 18-50 years in good physical health as determined by medical history, physical examination, and screening blood tests
- Normoglycemia defined by fasting plasma glucose < 5.6 mmol/L (or 100 mg/dL) and 2h glucose <7.8 mmol/L (or 140 mg/dL) after a 75 g OGTT
- BMI: 22.0 - 28.0 kg/m2
Exclusion Criteria:
- Presence of any disease or use of any medication
- Patients with a first-degree relative with Type 2 Diabetes
- Patients who smoke
- Patients with history of steroid use in previous 6 months.
- Patients who do shift work
- Signs or symptoms of infection.
- Patients with recent changes in weight or physical activity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prednisone in subjects with Diabetes
Prednisone in control subjects
Arm Description
Group of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Group of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
HOMA index
Comparison of Homeostatic model assessment (HOMA) index before and after receiving the prednisone dose (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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03661684
Brief Title
Effect of Short Course of Glucocorticoid in Patients With Diabetes Mellitus(DM) Type 2
Official Title
Glucocorticoid Effects in Patients With DM Type 2
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperglycemia Steroid-induced
Keywords
Diabetes, Glucocorticoids, Hyperglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone in subjects with Diabetes
Arm Type
Experimental
Arm Description
Group of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Arm Title
Prednisone in control subjects
Arm Type
Experimental
Arm Description
Group of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone, Prednicot, Rayos
Intervention Description
40 mg po q day of Prednisone for 3 days
Primary Outcome Measure Information:
Title
AUC for glucose during OGTT
Description
Comparison of the Area under the curve (AUC) of the OGTT for glucose values at 60 and 120 throughout the course of 3 days
Time Frame
Throughout the course of 3 days
Secondary Outcome Measure Information:
Title
HOMA index
Description
Comparison of Homeostatic model assessment (HOMA) index before and after receiving the prednisone dose (at day 1 and at day 3)
Time Frame
At day 1 and at day 3
Title
AUC for Insulin during OGTT
Description
Comparison of the Area under the curve of the OGTT for glucose values at 60 and 120 minutes throughout the course of 3 days
Time Frame
Throughout the course of 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Experimental Group
Inclusion Criteria:
Males or non-pregnant females between the ages of 18-50 years being followed in the Diabetes Center.
Type 2 Diabetes for ≤ 1 year and only on metformin
BMI 24.0-35.0 kg/ m2
HBA1c ≤ 9.0%
Exclusion Criteria:
Patients on any other antidiabetes medication.
Patients with impaired renal function (estimated Glomerular Filtration Rate (GFR) less than 60 ml/min based on results from Cerner).
Patient who have received glucocorticoid therapy within six months of study.
Patients who do shift work.
Blood glucose level ≥ 250 mg/dl on finger-stick at clinic visit.
Signs or symptoms of infection.
Control Group
Inclusion Criteria:
Males or non-pregnant females between the ages of 18-50 years in good physical health as determined by medical history, physical examination, and screening blood tests
Normoglycemia defined by fasting plasma glucose < 5.6 mmol/L (or 100 mg/dL) and 2h glucose <7.8 mmol/L (or 140 mg/dL) after a 75 g OGTT
BMI: 22.0 - 28.0 kg/m2
Exclusion Criteria:
Presence of any disease or use of any medication
Patients with a first-degree relative with Type 2 Diabetes
Patients who smoke
Patients with history of steroid use in previous 6 months.
Patients who do shift work
Signs or symptoms of infection.
Patients with recent changes in weight or physical activity
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16901792
Citation
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.
Results Reference
background
PubMed Identifier
24123849
Citation
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.
Results Reference
background
PubMed Identifier
21562755
Citation
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.
Results Reference
background
PubMed Identifier
32369480
Citation
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.
Results Reference
derived
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Effect of Short Course of Glucocorticoid in Patients With Diabetes Mellitus(DM) Type 2
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