HyperglycemiaNCT01087372
Stress Hyperglycemia. Potential Role of Incretin Analogs
An observational study of Hyperglycemia and Critical Illness, run by Hospital Universitari Son Dureta at 1 site in Spain.
Trial summary
This is a prospective observational study to examine the levels of glucoregulatory hormones, with special focus on incretins levels, in critically ill patients with stress hyperglycemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Critical Illness
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Apr 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical-surgical ICU patients
Who may be able to join
- Age > 18 years
- Emergent ICU admission
- Written informed consent from patient or relative.
Who cannot join
- Previously known type I or type II diabetes.
- Patients who received insulin or oral antidiabetic agents before ICU admission.
- Malignancies.
- Scheduled surgery
- Patients receiving enteral or parenteral nutrition.
- Inability to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Son Dureta. Intensive Care Unit
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study
This is a prospective observational study to examine the levels of glucoregulatory hormones, with special focus on incretins levels, in critically ill patients with stress hyperglycemia.
- Conditions
- Hyperglycemia, Critical Illness
- Keywords
- Stress hyperglycemia, Incretins, GLP-1, GIP, glucoregulatory hormones
- Medical subject headings
- Hyperglycemia, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretins plasmatic levels
28 days and ICU mortality
Measured: 28 days
Secondary outcomes (4)
glucagon
28 days and ICU mortality
Measured: 28 days
insulin
28 days and ICU mortality
Measured: 28 days
cortisol
28 days and ICU mortality
Measured: 28 days
HOMA index
28 days and ICU mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Mateu Orfila
- Investigators
- Juan A Llompart-Pou, M.D., Principal investigator, Hospital Universitari Son Dureta. Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087372
- Sponsor's protocol ID
- Incretins2010
- Status last verified
- Jun 2010
- First submitted
- 11 Mar 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Llompart-Pou JA, Fernandez-de-Castillo AG, Burguera B, Perez-Barcena J, Marse P, Rodriguez-Yago M, Barcelo A, Raurich JM. Stress hyperglycaemia in critically ill patients: potential role of incretin hormones; a preliminary study. Nutr Hosp. 2012 Jan-Feb;27(1):130-7. doi: 10.1590/S0212-16112012000100015.
PubMed 22566312
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Hyperglycemia in Critically Ill Patients. Potential Role of Incretin Analogs. A Preliminary Study
- ClinicalTrials.gov ID
- NCT01087372
- Acronym / sponsor ID
- Incretins2010
- Conditions
- Hyperglycemia, Critical Illness
- Keywords
- Stress hyperglycemia, Incretins, GLP-1, GIP, glucoregulatory hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Fundació Mateu Orfila
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Mar 2010 (estimated)
- 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.
This is a prospective observational study to examine the levels of glucoregulatory hormones, with special focus on incretins levels, in critically ill patients with stress hyperglycemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical-surgical ICU patients
Key inclusion criteria (3 listed)
- Age > 18 years
- Emergent ICU admission
- Written informed consent from patient or relative.
Key exclusion criteria (6 listed)
- Previously known type I or type II diabetes.
- Patients who received insulin or oral antidiabetic agents before ICU admission.
- Malignancies.
- Scheduled surgery
- Patients receiving enteral or parenteral nutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incretins plasmatic levels
Time frame: 28 days
28 days and ICU mortality
4 secondary outcomes
glucagon
Time frame: 28 days
insulin
Time frame: 28 days
cortisol
Time frame: 28 days
HOMA index
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
- Derived from this study: PubMed 22566312Llompart-Pou JA, Fernandez-de-Castillo AG, Burguera B, Perez-Barcena J, Marse P, Rodriguez-Yago M, Barcelo A, Raurich JM. Stress hyperglycaemia in critically ill patients: potential role of incretin hormones; a preliminary study. Nutr Hosp. 2012 Jan-Feb;27(1):130-7. doi: 10.1590/S0212-16112012000100015.
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
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.
Juan A Llompart-Pou, M.D. principal investigator
Hospital Universitari Son Dureta. Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Critical Illness, run by Hospital Universitari Son Dureta at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jun 2010. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incretins plasmatic levels (time frame: 28 days). 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 NCT01087372, which also lists 1 linked publication.
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 8 Jun 2010.