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

NCT03102801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-01

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus With Hypoglycemia

Interventions

DRUG

Humulin S

Humulin S used to induce hypoglycaemia

Sponsors & Collaborators

  • University of Hull

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-01-10
Completion
2018-01-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102801 on ClinicalTrials.gov