The Effects of Hypoglycaemia in People With Type 2 Diabetes

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 acute hypoglycaemia will result in platelet activation in people with type 2 diabetes to a higher degree than controls.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Hull
• Collaborators: Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust
• Treatments: Hypoglycemic Agents; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. 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.

2. 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 Criteria:

1. 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

2. 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