Effect of Short Course of Glucocorticoid in Patients With Diabetes Mellitus(DM) Type 2
Condition: Diabetes; Hyperglycemia Steroid-induced
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Prednisone
Intervention type(s): Drug
Intervention description(s): 40 mg po q day of Prednisone for 3 days
Other intervention name(s): Deltasone, Prednicot, Rayos
Intervention MeSH terms: Prednisone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes; Glucocorticoids; Hyperglycemia