CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Humulin Sdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03102801
NCT03102801N/ACompleted

A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes

University of Hull·interventional·Posted Apr 6, 2017·Updated Nov 1, 2018

In Brief

A clinical study evaluating Humulin S for Type 2 Diabetes Mellitus With Hypoglycemia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Glucose is a sugar carried in the blood stream that body uses for energy. If someone has diabetes, blood glucose level can be erratic, sometimes becoming very low this is called Hypoglycaemia (or a "hypo"), and can happen when blood glucose levels drop below 4 mmol/l. So far in order to prove that a hypo happened for a patient, blood glucose level can only be measured at time of the hypo and not after it. In this study we are trying to identify certain chemical substances (biomarkers) in diabetic patients that may be measured in blood tests of the patient up to after 24 hours of the hypo and if we could prove that a hypo has happened we could adjust tablets and or insulin dosage in a way to prevent further hypos. The study will be conducted in the Diabetes Centre in Hull Royal Infirmary and will involve three visits to the diabetes centre. The study can finish in a week time after the first visit. Visit 1 is the screening visit to identify eligibility to take part in the study. Visit 2 insulin infusion will be given to make participants blood sugar level fall lower than normal for a short time and corrected quickly afterward. This is a stress for participant's body and should stimulate certain chemicals that we are trying to identify during hypo. In Visit 3, the main purpose of this visit which is done 24 hours after insulin infusion is to take a blood sample and check how participants is after visit 2. We will recruit 25 Type 2 Diabetic patients and 25 none diabetics to compare both results. Both groups should not have ischemic heart disease, underactive thyroid or seizures and on stable dosage of medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 6, 2017
Enrollment StartMar 1, 2017
Primary CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.2 years ago

Interventions

Humulin Sdrug

Humulin S used to induce hypoglycaemia