Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart FailureNCT04922099
Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure
An observational study of Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart Failure, run by Assiut University.
Trial summary
assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart Failure
- What is being tested?
- glycemic gap
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure
Who may be able to join
- All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure
Who cannot join
- Age ≤18 years.
- Hypoglycemia (plasma glucose <70 mg/dL) at initial presentation.
- An admission diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- Patients with hemoglobin variants (e.g., sickle cell anemia, thalassemia) or with hematologic conditions (e.g., hemolytic anemia) that could interfere with the accuracy of the HbA1c assay.
About this study
assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure
Read the detailed description
Hyperglycemia is a common problem in patients wi9non-diabetic patients but not in patients with diabetes . The relationship between admission hyperglycemia and mortality in diabetic patients with AHF or critical illness remains controversial . Those discrepancies could be partly attributed to long-term glycemic control in diabetic patients.
Critical illness can induce stress-induced hyperglycemia (SIH), which results from the excess release of counter-regulatory hormones and anti-inflammatory cytokines, leading to augmented gluconeogenesis and insulin resistance.
In diabetic patients with acute illness, the phenomenon of admission hyperglycemia could be connected with acute physiological stress, poorer glycemic controls, or a combination of both . It is necessary to think about background glycemic control when exploring the relationships between admissions Hyperglycemia and clinical outcomes. Recent studies have shown that hemoglobin A1c (HbA1c)-based adjusted glycemic variables, including glycemic gap and stress hyperglycemia ratio, were linked to severity of disease and unfavorable prognosis in diabetic patients with some infectious diseases, cardiovascular diseases and clinical illness
- Being tested
- glycemic gap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycemic gapDevice
Measurements of HbA1c-based adjusted glycemic gap:
The estimated chronic average glucose levels (eAG) over the past 3 months will calculate from the equation AG = 28.7 × HbA1c - 46.7 Glycemic gap was calculated as the ADAG level subtracted from the admission glucose level.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
Measured: through study completion an avarage 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema Medhat Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922099
- Sponsor's protocol ID
- Glycemic gap
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lazzeri C, Valente S, Chiostri M, D'Alfonso MG, Spini V, Angelotti P, Gensini GF. Admission Glycaemia and Acute Insulin Resistance in Heart Failure Complicating Acute Coronary Syndrome. Heart Lung Circ. 2015 Nov;24(11):1074-80. doi: 10.1016/j.hlc.2015.04.171. Epub 2015 May 16.
PubMed 26031570de Miguel-Yanes JM, Gonzalo-Hernando C, Munoz-Rivas N, Mendez-Bailon M, Cava-Valenciano F, Torres-Macho J. First plasma glucose value after urgent admission and in-hospital mortality in acutely decompensated heart failure. Heart Lung. 2015 Mar-Apr;44(2):137-40. doi: 10.1016/j.hrtlng.2014.11.006. Epub 2014 Dec 18.
PubMed 25534479Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
PubMed 19465235Yang CJ, Liao WI, Wang JC, Tsai CL, Lee JT, Peng GS, Lee CH, Hsu CW, Tsai SH. Usefulness of glycated hemoglobin A1c-based adjusted glycemic variables in diabetic patients presenting with acute ischemic stroke. Am J Emerg Med. 2017 Sep;35(9):1240-1246. doi: 10.1016/j.ajem.2017.03.049. Epub 2017 Mar 22.
PubMed 28363620
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT04922099
- Acronym / sponsor ID
- Glycemic gap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Jun 2021 (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.
assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure
Detailed description
Hyperglycemia is a common problem in patients wi9non-diabetic patients but not in patients with diabetes . The relationship between admission hyperglycemia and mortality in diabetic patients with AHF or critical illness remains controversial . Those discrepancies could be partly attributed to long-term glycemic control in diabetic patients.
Critical illness can induce stress-induced hyperglycemia (SIH), which results from the excess release of counter-regulatory hormones and anti-inflammatory cytokines, leading to augmented gluconeogenesis and insulin resistance.
In diabetic patients with acute illness, the phenomenon of admission hyperglycemia could be connected with acute physiological stress, poorer glycemic controls, or a combination of both . It is necessary to think about background glycemic control when exploring the relationships between admissions Hyperglycemia and clinical outcomes. Recent studies have shown that hemoglobin A1c (HbA1c)-based adjusted glycemic variables, including glycemic gap and stress hyperglycemia ratio, were linked to severity of disease and unfavorable prognosis in diabetic patients with some infectious diseases, cardiovascular diseases and clinical illness
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure
Key inclusion criteria (1 listed)
- All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure
Key exclusion criteria (4 listed)
- Age ≤18 years.
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 |
|---|---|---|
| glycemic gapMeasurements of HbA1c-based adjusted glycemic gap: The estimated chronic average glucose levels (eAG) over the past 3 months will calculate from the equation AG = 28.7 × HbA1c - 46.7 Glycemic gap was calculated as the ADAG level subtracted from the admission glucose level. | Device | – |
Primary outcome
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
Time frame: through study completion an avarage 1 year
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Background: PubMed 26031570Lazzeri C, Valente S, Chiostri M, D'Alfonso MG, Spini V, Angelotti P, Gensini GF. Admission Glycaemia and Acute Insulin Resistance in Heart Failure Complicating Acute Coronary Syndrome. Heart Lung Circ. 2015 Nov;24(11):1074-80. doi: 10.1016/j.hlc.2015.04.171. Epub 2015 May 16.
- Background: PubMed 25534479de Miguel-Yanes JM, Gonzalo-Hernando C, Munoz-Rivas N, Mendez-Bailon M, Cava-Valenciano F, Torres-Macho J. First plasma glucose value after urgent admission and in-hospital mortality in acutely decompensated heart failure. Heart Lung. 2015 Mar-Apr;44(2):137-40. doi: 10.1016/j.hrtlng.2014.11.006. Epub 2014 Dec 18.
- Background: PubMed 19465235Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
- Background: PubMed 28363620Yang CJ, Liao WI, Wang JC, Tsai CL, Lee JT, Peng GS, Lee CH, Hsu CW, Tsai SH. Usefulness of glycated hemoglobin A1c-based adjusted glycemic variables in diabetic patients presenting with acute ischemic stroke. Am J Emerg Med. 2017 Sep;35(9):1240-1246. doi: 10.1016/j.ajem.2017.03.049. Epub 2017 Mar 22.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart Failure, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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.
Are results available for this study?
Results are not available in the source record.
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?
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure (time frame: through study completion an avarage 1 year). 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 NCT04922099, 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 10 Jun 2021.