An observational study in Hypoglycemia, sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain. Completed at 1 site in Bahrain. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain · Observational
The study aims to obtain a panel of biomarkers from hypoglycemic diabetic patients with either type 1 or type 2 diabetics and from control patients with type 1 or type 2 diabetes who didn't have hypoglycemia in the last 72 hours.
Primary endpoint is establishing a panel of biomarkers from 100 hypoglycemic diabetic patients with type 1 or type 2 Diabetes during the incidence of hypoglycemia by taking a single blood sample to be analyzed for HbA1c, LDL, HDL, Triglycerides, CRP, CBC and biochemical analysis including liver and kidney function tests. In addition to 5 ml serum sample to be centrifuged and stored in RCSI lab.
Inpatient hypoglycemic patients may also be included in group of hypoglycemia and will be required to have a serial of blood samples taken to be analyzed on the 1st hour, 2nd hour, 3rd hour and 4th hour after the hypoglycemic event.
Secondary endpoint involves recruitment of 100 control Diabetic patients with type 1 or type 2 Diabetes to establish a panel of biomarkers by obtaining a blood sample for the HbA1c, LDL, HDL, Triglycerides, CRP, CBC and biochemical analysis including liver and kidney function tests to include 50 subjects fasting overnight and the other 50 subjects to be non-fasting but without having hypoglycemia at the time of recruitment or in the last 72 hours.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 150 is above the median of 86 across 131 observational studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Royal College of Surgeons in Ireland - Medical University of Bahrain is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Type 1 or type 2 Diabetic subjects with and without hypoglycemic event to be included either in hypoglycemic group or in Control group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion criteria for diabetes subjects with hypoglycemia
Inclusion criteria for diabetes subjects without hypoglycemia:
Exclusion Criteria:
Exclusion Criteria for diabetes subjects with hypoglycemia
Exclusion criteria for diabetes subjects without hypoglycemia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypoglycemic diabetic patients with type 1 or type 2 diabetes recruited during the incidence of hypoglycemia with awareness of the time when hypoglycemia occurred.
Type 1 or type 2 diabetic subjects who don't have hypoglycemia at the time of recruitment or in the last 72 hours.
Concentrations of a Panel of Protein Biomarkers in hypoglycemic subjects
a panel of biomarkers is measured from a blood test taken during the incidence of hypoglycemia from type 1 or type 2 Diabetic subject.
Time frame: 1 day from time of presentation
Concentrations of a Panel of Protein Biomarkers Reference Ranges from non-hypoglycemic diabetic subjects
a panel of biomarkers is measured from a blood test taken from Diabetic subjects (type 1 or type 2) without having hypoglycemia.
Time frame: 3 days from time of presentation
CBC
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
CRP
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
LDL
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
HDL
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
Triglycerides
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
Biochemical analysis
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
HbA1C%
Measured from a blood test taken from Diabetic subjects (type 1 or type 2) control group and hypoglycemic patients
Time frame: 1 day from time of presentation
Plan to share: Yes — Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Dr Naji will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.
Access criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.
Ran from Mar 2024 to primary completion in Sep 2024, 6 months.
Of 52 non-industry observational studies under Hypoglycemia, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's 6 months is below that.
Counting every sponsor, half of 53 studies reached it within 22 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons in Ireland - Medical University of Bahrain