Diabetes MellitusPhase 4NCT03646916
Intraoperative Dexamethasone and Its Effect on Hyperglycemia
A Phase 4 study testing Dexamethasone and No dexamethasone in people with Diabetes Mellitus, run by Ascension Health at 1 site in United States.
Trial summary
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dexamethasone and No dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Dec 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on steroid therapy
- Pregnant women
- Patients at low risk for nausea/vomiting
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Dexamethasone, No dexamethasone
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Gluco-corticosteroid
No dexamethasoneOther
Nothing
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone; Other: No dexamethasone |
| Non-treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative blood sugar
Measured: 24 hour Post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start15 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tarik Wasfie, MD, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646916
- Sponsor's protocol ID
- GRMC160010
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03646916
- Acronym / sponsor ID
- GRMC160010
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone, Other: No dexamethasone |
| Non-treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients on steroid therapy
- Pregnant women
- Patients at low risk for nausea/vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneGluco-corticosteroid | Drug | Dexamethasone |
| No dexamethasoneNothing | Other | Dexamethasone |
Primary outcome
Post-operative blood sugar
Time frame: 24 hour Post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Related trials for Diabetes Mellitus
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and No dexamethasone in people with Diabetes Mellitus, run by Ascension Health at 1 site in United States.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Post-operative blood sugar (time frame: 24 hour Post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.