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

September 25, 2023 updated by: Yannis Guerra, Cook County Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prednisone in subjects with Diabetes
Group of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Drug: Prednisone
40 mg po q day of Prednisone for 3 days
Other Names:
  • Deltasone, Prednicot, Rayos
Experimental: Prednisone in control subjects
Group of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days
Drug: Prednisone
40 mg po q day of Prednisone for 3 days
Other Names:
  • Deltasone, Prednicot, Rayos

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC for glucose during OGTT
Time Frame: Throughout the course of 3 days
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HOMA index
Time Frame: At day 1 and at day 3
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
Time Frame: Throughout the course of 3 days
Comparison of the Area under the curve of the OGTT for glucose values at 60 and 120 minutes throughout the course of 3 days
Throughout the course of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cook County Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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