Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event

NCT06652867 | Completed DMC

• 1 other identifier: 400 / 05-Feb-2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Keywords

type 1 Diabetes; Type 2 Diabetes; Hypoglycemia Biomarkers

Outcome Measures

Primary Outcomes (1)

• Concentrations of a Panel of Protein Biomarkers in hypoglycemic subjects

  a panel of biomarkers is measured from a blood test taken during the incidence of hypoglycemia from type 1 or type 2 Diabetic subject.

  1 day from time of presentation

Secondary Outcomes (1)

• Concentrations of a Panel of Protein Biomarkers Reference Ranges from non-hypoglycemic diabetic subjects

  3 days from time of presentation

Other Outcomes (7)

• CBC

  1 day from time of presentation

• CRP

  1 day from time of presentation

• LDL

  1 day from time of presentation

Study Arms (2)

Hypoglycemic diabetic patients

Hypoglycemic diabetic patients with type 1 or type 2 diabetes recruited during the incidence of hypoglycemia with awareness of the time when hypoglycemia occurred.

Control group of non-hypoglycemic diabetic patients.

Type 1 or type 2 diabetic subjects who don't have hypoglycemia at the time of recruitment or in the last 72 hours.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• King Hamad University Hospital, Bahrain: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland

Manama, Bahrain

Location

Related Publications (16)

• Wei M, Gibbons LW, Mitchell TL, Kampert JB, Stern MP, Blair SN. Low fasting plasma glucose level as a predictor of cardiovascular disease and all-cause mortality. Circulation. 2000 May 2;101(17):2047-52. doi: 10.1161/01.cir.101.17.2047.

  PMID: 10790345 BACKGROUND

• Goto A, Arah OA, Goto M, Terauchi Y, Noda M. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ. 2013 Jul 29;347:f4533. doi: 10.1136/bmj.f4533.

  PMID: 23900314 BACKGROUND

• Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, Dudl RJ, Ismail-Beigi F, Kimel AR, Hoogwerf B, Horowitz KR, Savage PJ, Seaquist ER, Simmons DL, Sivitz WI, Speril-Hillen JM, Sweeney ME. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b4909. doi: 10.1136/bmj.b4909.

  PMID: 20061358 BACKGROUND

• Graveling AJ, Frier BM. Hypoglycaemia: an overview. Prim Care Diabetes. 2009 Aug;3(3):131-9. doi: 10.1016/j.pcd.2009.08.007. Epub 2009 Sep 24.

  PMID: 19782016 BACKGROUND

• UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007 Jun;50(6):1140-7. doi: 10.1007/s00125-007-0599-y. Epub 2007 Apr 6.

  PMID: 17415551 BACKGROUND

• Henderson JN, Allen KV, Deary IJ, Frier BM. Hypoglycaemia in insulin-treated Type 2 diabetes: frequency, symptoms and impaired awareness. Diabet Med. 2003 Dec;20(12):1016-21. doi: 10.1046/j.1464-5491.2003.01072.x.

  PMID: 14632703 BACKGROUND

• Chico A, Vidal-Rios P, Subira M, Novials A. The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes Care. 2003 Apr;26(4):1153-7. doi: 10.2337/diacare.26.4.1153.

  PMID: 12663589 BACKGROUND

• Leiter LA, J.F. Y, Chiasson JL, Harris SB, Kleinstiver P, Sauriol L. Assessment of the impact of fear of hypoglycemic episodes on glycemic and hypoglycemia management. Canadian Journal of Diabetes. 2005;29:186-92.

  BACKGROUND

• Brod M, Alolga SL, Meneghini L. Barriers to initiating insulin in type 2 diabetes patients: development of a new patient education tool to address myths, misconceptions and clinical realities. Patient. 2014;7(4):437-50. doi: 10.1007/s40271-014-0068-x.

  PMID: 24958464 BACKGROUND

• Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.

  PMID: 22111719 BACKGROUND

• Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.

  PMID: 22313123 BACKGROUND

• Kilpatrick ES, Rigby AS, Warren RE, Atkin SL. Implications of new European Union driving regulations on patients with Type 1 diabetes who participated in the Diabetes Control and Complications Trial. Diabet Med. 2013 May;30(5):616-9. doi: 10.1111/dme.12075. Epub 2013 Feb 28.

  PMID: 23215789 BACKGROUND

• Hepburn DA, Frier BM. Hypoglycemia Unawareness in Patients with Insulin-Treated Diabetes-Mellitus. Saudi Medical Journal. 1991;12(3):182-90.

  BACKGROUND

• Gold L, Ayers D, Bertino J, Bock C, Bock A, Brody EN, Carter J, Dalby AB, Eaton BE, Fitzwater T, Flather D, Forbes A, Foreman T, Fowler C, Gawande B, Goss M, Gunn M, Gupta S, Halladay D, Heil J, Heilig J, Hicke B, Husar G, Janjic N, Jarvis T, Jennings S, Katilius E, Keeney TR, Kim N, Koch TH, Kraemer S, Kroiss L, Le N, Levine D, Lindsey W, Lollo B, Mayfield W, Mehan M, Mehler R, Nelson SK, Nelson M, Nieuwlandt D, Nikrad M, Ochsner U, Ostroff RM, Otis M, Parker T, Pietrasiewicz S, Resnicow DI, Rohloff J, Sanders G, Sattin S, Schneider D, Singer B, Stanton M, Sterkel A, Stewart A, Stratford S, Vaught JD, Vrkljan M, Walker JJ, Watrobka M, Waugh S, Weiss A, Wilcox SK, Wolfson A, Wolk SK, Zhang C, Zichi D. Aptamer-based multiplexed proteomic technology for biomarker discovery. PLoS One. 2010 Dec 7;5(12):e15004. doi: 10.1371/journal.pone.0015004.

  PMID: 21165148 BACKGROUND

• Suhre K, Arnold M, Bhagwat AM, Cotton RJ, Engelke R, Raffler J, Sarwath H, Thareja G, Wahl A, DeLisle RK, Gold L, Pezer M, Lauc G, El-Din Selim MA, Mook-Kanamori DO, Al-Dous EK, Mohamoud YA, Malek J, Strauch K, Grallert H, Peters A, Kastenmuller G, Gieger C, Graumann J. Connecting genetic risk to disease end points through the human blood plasma proteome. Nat Commun. 2017 Feb 27;8:14357. doi: 10.1038/ncomms14357.

  PMID: 28240269 BACKGROUND

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  PMID: 22022604 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 ml of centrifuged serum blood sample will be retained.

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Naji Alamuddin, Dr.

  Bahrain Royal Medical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: October 22, 2024
• Study Start: March 3, 2024
• Primary Completion: September 25, 2024
• Study Completion: October 1, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Dr Naji will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.
• Access Criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.

Locations

BA (1)