Clinical trial NCT06652867: Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event
Official title: Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Keywords: type 1 Diabetes
Type 2 Diabetes
Hypoglycemia Biomarkers
Lead sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain
Sponsor class: OTHER
Collaborators: name: King Hamad University Hospital, Bahrain
First posted: 2024-10-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 or type 2 Diabetic subjects with and without hypoglycemic event to be included either in hypoglycemic group or in Control group.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for diabetes subjects with hypoglycemia

* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines Patient's age from 21-75 years old
* Able to say when the hypo had occurred (free style libre in the outpatient setting, or documented blood glucose less than \< 4 mmol/l (\<70 mg/dl) as an inpatient

Inclusion criteria for diabetes subjects without hypoglycemia:

* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines
* Patient's age from 21-75 years old
* No hypoglycemia or hypoglycemia unawareness.

Exclusion Criteria:

* eGFR less than 45 ml/min
* Liver enzymes 3 folds greater than upper limit
* Pregnancy
* Patients on steroids or Atypical Antipsychotics or Cyclosporine/Tacrolimus or other medications that may mask hypoglycemia

Exclusion Criteria for diabetes subjects with hypoglycemia

* Unable to determine when hypoglycemic event had taken place
* Hypoglycemic unawareness
* Severe hypoglycemic event in the last 3 months

Exclusion criteria for diabetes subjects without hypoglycemia

* Hypoglycemic event in the preceding week
* Hypoglycemic unawareness

Primary outcomes:
measure: Concentrations of a Panel of Protein Biomarkers in hypoglycemic subjects
timeFrame: 1 day from time of presentation
Secondary outcomes:
measure: Concentrations of a Panel of Protein Biomarkers Reference Ranges from non-hypoglycemic diabetic subjects
timeFrame: 3 days from time of presentation
Other outcomes:
measure: CBC
timeFrame: 1 day from time of presentation
measure: CRP
timeFrame: 1 day from time of presentation
measure: LDL
timeFrame: 1 day from time of presentation
measure: HDL
timeFrame: 1 day from time of presentation
measure: Triglycerides
timeFrame: 1 day from time of presentation
measure: Biochemical analysis
timeFrame: 1 day from time of presentation
measure: HbA1C%
timeFrame: 1 day from time of presentation
Locations:
city: Manama
country: Bahrain
facility: Royal College of Surgeons in Ireland
Study officials:
affiliation: Bahrain Royal Medical Services
name: Naji Alamuddin, Dr.
role: PRINCIPAL_INVESTIGATOR
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