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

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ClinicalTrials.gov Identifier: NCT03102801
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Thozhukat Sathyapalan, University of Hull

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus With Hypoglycemia Drug: Humulin S Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes
Study Start Date : December 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Active Comparator: Type 2 diabetes arm
Both arms will be subjected to Hypoglycaemia and compare results
Drug: Humulin S
Active Comparator: Non diabetics arm
Both arms will be subjected to Hypoglycaemia and compare results
Drug: Humulin S



Primary Outcome Measures :
  1. Measurement of endothelial microparticles (composite number of CD105, CD106, CD142, CD54, CD62 & CD31) following hypoglycemic event [ Time Frame: 6 months ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for diabetic patients.

  1. Men and women who are white British or white Europeans between 40 - 70 years of age with type 2 diabetes.
  2. Duration of diabetes less than 10 years.
  3. Stable dose of medication over the last 3 months.
  4. No history of severe hypoglycemic in the preceding 3 months.
  5. No hypoglycemic unawareness
  6. Able to give informed consent.

Exclusion Criteria for diabetic patients.

  1. Type 1 diabetes.
  2. Duration of diabetes of more than 10 years.
  3. Patients who are on insulin.
  4. HbA1c of ≥ 10%.
  5. BMI <18 or >50 kg/m2
  6. Alcohol excess defined as 14 units per week for a man or a woman. Binge drinking is defined 6 units for a man or women in a single drinking session.
  7. Renal impairment with estimated Glomerular Filtration Rate (eGFR<60 ml/min/1.73 m2).
  8. Impaired Liver function tests defined as ALT or AST more than or equal 2.5 times upper limit of the normal.
  9. History or presence of malignant neoplasms within the last 5 years( except basal and squamous cell skin cancer and in-situ carcinoma).
  10. Psychiatric illness.
  11. Any form of gastrointestinal tract surgery.
  12. Any medications that can mask Hypoglycaemia such as B-Blockers or Clonidine.
  13. Medication that may cause change in glucose metabolism.
  14. Patients on any form of steroids in the last six months.
  15. Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods.
  16. History of pancreatitis (Acute or Chronic).
  17. History of severe hypoglycaemia or hypoglycaemic unawareness.
  18. Any disorder which in the opinion of the investigator might jeopardize subject`s safety.
  19. Contraindications to insulin infusion aiming for hypoglycaemia:

    • Ischaemic heart disease.
    • Epilepsy or previous history of seizures.
    • Drop attacks.
    • History of adrenal insufficiency.
    • Untreated hypothyroidism.

Inclusion Criteria for the control group.

  1. Men and women who are white British or white Europeans between 40 - 70 years of age.
  2. Stable dose of medications in last 3 months.
  3. Able to give informed consent.

Exclusion Criteria for the control group

  1. History of diabetes
  2. BMI <18 or >50 kg/m2
  3. HbA1C>6% (42mmol/mol)
  4. Alcohol excess defined as 14 units per week for a man or a women. Binge drinking is defined 6 units for a man or women in a single drinking session.
  5. Renal impairment with estimated Glomerular Filtration Rate (eGFR<60 ml/min/1.73 m2).
  6. Impaired Liver function tests defined as ALT or AST more than or equal 2.5 times upper limit of the normal.
  7. History or presence of malignant neoplasms within the last 5 years( except basal and squamous cell skin cancer and in-situ carcinoma).
  8. Psychiatric illness
  9. Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods.
  10. Medication that may cause change in glucose metabolism
  11. Any form of gastrointestinal tract surgery.
  12. Patient on any form of steroids in the last 6 months.
  13. Any disorder which in the opinion of the investigator might jeopardize subject`s safety.
  14. Contraindications to insulin infusion aiming for hypoglycaemia:

    • Ischaemic heart disease.
    • Epilepsy or previous history of seizures.
    • Drop attacks.
    • History of adrenal insufficiency.
    • Untreated hypothyroidism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102801


Contacts
Contact: Thozhukat Sathyapalan, MD FRCP 01482675312 thozhukat.sathyapalan@hyms.ac.uk
Contact: Ahmed Al-Qaissi, MRCP 01482675314 a.al-qaissi@hull.ac.uk

Locations
United Kingdom
Hull and east Yorkshire Hospitals NHS Trust Recruiting
Hull, United Kingdom, HU32RW
Contact: Thozhukat Sathyapalan, MD FRCP    01482675312    thozhukat.sathyaplan@hyms.ac.uk   
Contact: Ahmed Al-Qaissi, MRCP    01482675314    a.al-qaissi@hull.ac.uk   
Sponsors and Collaborators
University of Hull

Responsible Party: Thozhukat Sathyapalan, Professor, University of Hull
ClinicalTrials.gov Identifier: NCT03102801     History of Changes
Other Study ID Numbers: Version 2
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases