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

NCT03661684 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 16-035
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Hyperglycemia Steroid-induced

Keywords

Diabetes; Glucocorticoids; Hyperglycemia

Outcome Measures

Primary Outcomes (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

  Throughout the course of 3 days

Secondary Outcomes (2)

• HOMA index

  At day 1 and at day 3

• AUC for Insulin during OGTT

  Throughout the course of 3 days

Study Arms (2)

Prednisone in subjects with Diabetes

EXPERIMENTAL

Group of subjects with diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days

Drug: Prednisone

Prednisone in control subjects

EXPERIMENTAL

Group of subjects without diabetes mellitus type 2 receiving prednisone 40 mg po q day for 3 days

Drug: Prednisone

Interventions

Prednisone DRUG

40 mg po q day of Prednisone for 3 days

Also known as: Deltasone, Prednicot, Rayos

Prednisone in control subjects; Prednisone in subjects with Diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Cook County Health: lead

Related Publications (4)

• 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.

  PMID: 16901792 BACKGROUND

• 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.

  PMID: 24123849 BACKGROUND

• 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.

  PMID: 21562755 BACKGROUND

• 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.

  PMID: 32369480 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinology Attending

Model Details: Two groups. Condition group and Control group, both receiving the investigated medication using the same protocol

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: September 7, 2018
• Study Start: June 3, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share