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DiabetesEarly Phase 1NCT03661684

Effect of Short Course of Glucocorticoid in Patients With Diabetes Mellitus(DM) Type 2

A Early Phase 1 study testing Prednisone in people with Diabetes and Hyperglycemia Steroid-induced, run by Cook County Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Hyperglycemia Steroid-induced
What is being tested?
Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
3 Jun 2016to 1 Jul 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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%
  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • Control Group
  • 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

About this study

Official title: Glucocorticoid Effects in Patients With DM Type 2

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.

Read the 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.

Being tested
Prednisone
Keywords
Diabetes, Glucocorticoids, Hyperglycemia
Medical subject headings
Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    Also called Deltasone, Prednicot, Rayos

    40 mg po q day of Prednisone for 3 days

Study groups in NCT03661684
Study groupRoleWhat they receive
Prednisone in subjects with DiabetesExperimentalGroup of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Receives: Drug: Prednisone
Prednisone in control subjectsExperimentalGroup of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Throughout the course of 3 days

Secondary outcomes (2)

  1. HOMA index

    Comparison of Homeostatic model assessment (HOMA) index before and after receiving the prednisone dose (at day 1 and at day 3)

    Measured: At day 1 and at day 3

  2. 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

    Measured: Throughout the course of 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start3 Jun 2016
  3. Primary completion1 Apr 2017
  4. Study completion1 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Model description
Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03661684
Sponsor's protocol ID
16-035
Status last verified
Sep 2023
First submitted
1 Jun 2017
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16901792

  • 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.

    PubMed 24123849

  • 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.

    PubMed 21562755

  • 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.

    PubMed 32369480

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Prednisone in people with Diabetes and Hyperglycemia Steroid-induced, run by Cook County Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC for glucose during OGTT (time frame: Throughout the course of 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03661684, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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