Status:
COMPLETED
The Effects of Hypoglycaemia in People With Type 2 Diabetes
Lead Sponsor:
University of Hull
Collaborating Sponsors:
Hull University Teaching Hospitals NHS Trust
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
Strict glycaemic control has been associated with increased hypoglycaemia and mortality rate, the cause of which was unclear, in subjects with type 2 diabetes. In this study, we hypothesised that acut...
Detailed Description
Type 2 diabetes is associated with increased risk of cardiovascular disease. Although the United Kingdom Prospective Diabetes Study (UKPDS) follow-up data suggested reduced macrovascular complications...
Eligibility Criteria
Inclusion
- Healthy volunteers:
- Males or females
- On no medications except for the contraceptive pill and without medical illnesses in the last three months.
- Non-smokers
- 40 - 60 years of age.
- T2DM subjects:
- Males or females
- Diagnosis of T2DM
- 40 - 60 years of age
- HbA1C: 6.5 - 9.5%
- Duration of diabetes 1 - 10 years
- Diabetes treated with diet, or tablets only.
Exclusion
- Healthy volunteers:
- Pregnancy
- Lack of contraception in women of child bearing age
- Chronic medical conditions
- Current smokers
- Evidence of ischaemia on ECG
- Drop attacks
- Alcohol or drug abuse
- Psychiatric illness
- Previous history of seizure
- Alcohol or drug abuse
- Type 2 diabetes subjects:
- Pregnancy
- Current smokers
- Recurrent episodes of hypoglycaemia
- Treatment with anti-platelet or anti-coagulation therapy
- History of ischaemic heart disease, stroke or peripheral vascular disease
- Epilepsy
- Drop attacks
- Evidence of ischaemia on ECG
- Insulin treated T2DM
- History of microvascular disease (retinopathy, nephropathy or neuropathy).
- Alcohol or drug abuse
- Psychiatric illness
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02205996
Start Date
November 1 2011
End Date
May 1 2013
Last Update
August 1 2014
Active Locations (1)
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1
Hull Royal Infirmary
Hull, United Kingdom, HU3 2RW