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Intraoperative Dexamethasone and Its Effect on Hyperglycemia

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ClinicalTrials.gov Identifier: NCT03646916
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tarik Wasfie, MD, Genesys Regional Medical Center

Brief Summary:
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Dexamethasone Other: No dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone Drug: Dexamethasone
Gluco-corticosteroid

Other: No dexamethasone
Nothing

No Intervention: Non-treatment



Primary Outcome Measures :
  1. Post-operative blood sugar [ Time Frame: 24 hour Post surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented history of Type I or Type II Diabetes Mellitus
  • scheduled for surgery that requires patients to be admitted for at least 24 hours post-surgery

Exclusion Criteria:

  • Patients on steroid therapy
  • Pregnant women
  • Patients at low risk for nausea/vomiting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646916


Contacts
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Contact: Tarik Wasfie, MD 810-720-2710 twasfie@gmail.com
Contact: Cindy Huckabone, BSN 810-606-5377 cynthia.huckabone@ascension.org

Locations
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United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys Regional Medical Center

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Responsible Party: Tarik Wasfie, MD, Principal Investigator, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT03646916     History of Changes
Other Study ID Numbers: GRMC160010
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action