A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes
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.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2018-01-10
- Completion
- 2018-01-10
Publications
- Moin ASM, Nandakumar M, Diboun I, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Hypoglycemia-induced changes in complement pathways in type 2 diabetes. Atheroscler Plus. 2021 Nov 18;46:35-45. doi: 10.1016/j.athplu.2021.11.002. eCollection 2021 Dec.
- Ramanjaneya M, Bettahi I, Pawar K, Halabi NM, Moin ASM, Sathyapalan T, Abou-Samra AB, Atkin SL, Butler AE. MicroRNA Changes Up to 24 h following Induced Hypoglycemia in Type 2 Diabetes. Int J Mol Sci. 2022 Nov 24;23(23):14696. doi: 10.3390/ijms232314696.
- Moin ASM, Sathyapalan T, Atkin SL, Butler AE. The severity and duration of Hypoglycemia affect platelet-derived protein responses in Caucasians. Cardiovasc Diabetol. 2022 Oct 6;21(1):202. doi: 10.1186/s12933-022-01639-w.
- Ramanjaneya M, Priyanka R, Bensila M, Jerobin J, Pawar K, Sathyapalan T, Abou-Samra AB, Halabi NM, Moin ASM, Atkin SL, Butler AE. MiRNA and associated inflammatory changes from baseline to hypoglycemia in type 2 diabetes. Front Endocrinol (Lausanne). 2022 Aug 9;13:917041. doi: 10.3389/fendo.2022.917041. eCollection 2022.
- Nandakumar M, Moin ASM, Ramanjaneya M, Qaissi AA, Sathyapalan T, Atkin SL, Butler AE. Severe iatrogenic hypoglycaemia modulates the fibroblast growth factor protein response. Diabetes Obes Metab. 2022 Aug;24(8):1483-1497. doi: 10.1111/dom.14716. Epub 2022 May 3.
- Moin ASM, Nandakumar M, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Potential Biomarkers to Predict Acute Ischemic Stroke in Type 2 Diabetes. Front Mol Biosci. 2021 Dec 1;8:744459. doi: 10.3389/fmolb.2021.744459. eCollection 2021.
- Butler AE, Al-Qaissi A, Sathyapalan T, Atkin SL. Angiopoietin-1: an early biomarker of diabetic nephropathy? J Transl Med. 2021 Oct 13;19(1):427. doi: 10.1186/s12967-021-03105-9. No abstract available.
- Atkin AS, Moin ASM, Nandakumar M, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Impact of severe hypoglycemia on the heat shock and related protein response. Sci Rep. 2021 Aug 23;11(1):17057. doi: 10.1038/s41598-021-96642-8.
- Moin ASM, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Soluble Neuropilin-1 Response to Hypoglycemia in Type 2 Diabetes: Increased Risk or Protection in SARS-CoV-2 Infection? Front Endocrinol (Lausanne). 2021 Jun 23;12:665134. doi: 10.3389/fendo.2021.665134. eCollection 2021.
- Moin ASM, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Type 2 Diabetes Coagulopathy Proteins May Conflict With Biomarkers Reflective of COVID-19 Severity. Front Endocrinol (Lausanne). 2021 Jun 25;12:658304. doi: 10.3389/fendo.2021.658304. eCollection 2021.
- Moin ASM, Kahal H, Al-Qaissi A, Kumar N, Sathyapalan T, Atkin SL, Butler AE. Amyloid-related protein changes associated with dementia differ according to severity of hypoglycemia. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e002211. doi: 10.1136/bmjdrc-2021-002211.
- Atkin AS, Moin ASM, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Plasma heat shock protein response to euglycemia in type 2 diabetes. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e002057. doi: 10.1136/bmjdrc-2020-002057.
- Moin ASM, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Platelet Protein-Related Abnormalities in Response to Acute Hypoglycemia in Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Mar 30;12:651009. doi: 10.3389/fendo.2021.651009. eCollection 2021.
- Moin ASM, Sathyapalan T, Diboun I, Atkin SL, Butler AE. Identification of macrophage activation-related biomarkers in obese type 2 diabetes that may be indicative of enhanced respiratory risk in COVID-19. Sci Rep. 2021 Mar 19;11(1):6428. doi: 10.1038/s41598-021-85760-y.
- Moin ASM, Al-Qaissi A, Sathyapalan T, Atkin SL, Butler AE. Do biomarkers of COVID-19 severity simply reflect a stress response in type 2 diabetes: Biomarker response to hypoglycemia. Metabolism. 2021 Jan;114:154417. doi: 10.1016/j.metabol.2020.154417. Epub 2020 Nov 4. No abstract available.
- Moin ASM, Sathyapalan T, Atkin SL, Butler AE. Pro-fibrotic M2 macrophage markers may increase the risk for COVID19 in type 2 diabetes with obesity. Metabolism. 2020 Nov;112:154374. doi: 10.1016/j.metabol.2020.154374. Epub 2020 Sep 16. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Humulin S | Unknown | — | — |