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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
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes focused on measuring Diabetes, Glucocorticoids, Hyperglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Experimental Group

Inclusion Criteria:

  1. Males or non-pregnant females between the ages of 18-50 years being followed in the Diabetes Center.
  2. Type 2 Diabetes for ≤ 1 year and only on metformin
  3. BMI 24.0-35.0 kg/ m2
  4. HBA1c ≤ 9.0%

Exclusion Criteria:

  1. Patients on any other antidiabetes medication.
  2. Patients with impaired renal function (estimated Glomerular Filtration Rate (GFR) less than 60 ml/min based on results from Cerner).
  3. Patient who have received glucocorticoid therapy within six months of study.
  4. Patients who do shift work.
  5. Blood glucose level ≥ 250 mg/dl on finger-stick at clinic visit.
  6. Signs or symptoms of infection.

Control Group

Inclusion Criteria:

  1. 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
  2. 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
  3. BMI: 22.0 - 28.0 kg/m2

Exclusion Criteria:

  1. Presence of any disease or use of any medication
  2. Patients with a first-degree relative with Type 2 Diabetes
  3. Patients who smoke
  4. Patients with history of steroid use in previous 6 months.
  5. Patients who do shift work
  6. Signs or symptoms of infection.
  7. 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

    First Posted
    June 1, 2017
    Last Updated
    September 25, 2023
    Sponsor
    Cook County Health
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    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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