NCT03102801

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

Completed NA Last updated 1 November 2018

What this trial tests

NA trial testing Humulin S in Type 2 Diabetes Mellitus With Hypoglycemia in 50 participants. Completed in 10 January 2018.

Timeline

1 March 2017

Primary endpoint
10 January 2018

10 January 2018

Quick facts

Lead sponsor	University of Hull
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	50
Start date	1 March 2017
Primary completion	10 January 2018
Estimated completion	10 January 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Humulin S — full drug profile →

Conditions studied

• Type 2 Diabetes Mellitus With Hypoglycemia — all drugs for Type 2 Diabetes Mellitus With Hypoglycemia →

Sponsor

University of Hull

Who can join

Adults 40 to 70, any sex, with Type 2 Diabetes Mellitus With Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Potentials of Extracellular Vesicles for the Treatment of Diabetes and Diabetic Complications.
   Hu W, Song X, Yu H, Sun J, et al · · 2020 · cited 37× · PMID 32708290 · DOI 10.3390/ijms21145163
2. Identification of macrophage activation-related biomarkers in obese type 2 diabetes that may be indicative of enhanced respiratory risk in COVID-19.
   Moin ASM, Sathyapalan T, Diboun I, Atkin SL, et al · · 2021 · cited 16× · PMID 33742062 · DOI 10.1038/s41598-021-85760-y
3. Impact of severe hypoglycemia on the heat shock and related protein response.
   Atkin AS, Moin ASM, Nandakumar M, Al-Qaissi A, et al · · 2021 · cited 12× · PMID 34426634 · DOI 10.1038/s41598-021-96642-8
4. Plasma heat shock protein response to euglycemia in type 2 diabetes.
   Atkin AS, Moin ASM, Al-Qaissi A, Sathyapalan T, et al · · 2021 · cited 11× · PMID 33879515 · DOI 10.1136/bmjdrc-2020-002057
5. Hypoglycemia-induced changes in complement pathways in type 2 diabetes.
   Moin ASM, Nandakumar M, Diboun I, Al-Qaissi A, et al · · 2021 · cited 8× · PMID 36643727 · DOI 10.1016/j.athplu.2021.11.002
6. MiRNA and associated inflammatory changes from baseline to hypoglycemia in type 2 diabetes.
   Ramanjaneya M, Priyanka R, Bensila M, Jerobin J, et al · · 2022 · cited 8× · PMID 36017315 · DOI 10.3389/fendo.2022.917041
7. Diagnostic and Prognostic Protein Biomarkers of β-Cell Function in Type 2 Diabetes and Their Modulation with Glucose Normalization.
   Moin ASM, Sathyapalan T, Atkin SL, Butler AE. · · 2022 · cited 8× · PMID 35323639 · DOI 10.3390/metabo12030196
8. Potential Biomarkers to Predict Acute Ischemic Stroke in Type 2 Diabetes.
   Moin ASM, Nandakumar M, Al-Qaissi A, Sathyapalan T, et al · · 2021 · cited 7× · PMID 34926573 · DOI 10.3389/fmolb.2021.744459