None listed
Conditions
Brief summary
Diabetes is a disorder of blood sugar and requires treatment for high blood sugar levels using drugs such as insulin. However, treatments like insulin can cause excessively low blood sugar levels (hypoglycaemia). If unrecognised and untreated hypoglycaemia can induce a coma. To protect against hypoglycaemia certain physiological responses occur. These include release of hormones that break down stores of sugar within the body and emptying the stomach quicker so that nutrient can be absorbed more rapidly. Both physiological responses will increase blood sugar levels. Recent evidence suggests that episodes of low blood sugar levels impair the hormonal response to subsequent episodes of hypoglycaemia, but the effect of these antecedent episodes of hypoglycaemia on gastric emptying rate during subsequent hypoglycaemia is unknown. This study aims to investigate whether there are changes in gastric emptying following repeated hypoglycaemic episodes. In addition this study will assess changes in glucose absorption, autonomic nerve function, secretion of catecholamine, glucagon and pancreatic polypeptide and cardiac function. Null hypothesis: Recurrent hypoglycaemia does not effect hypoglycaemia-induced acceleration of gastric emptying.
Interventions
Antecedent hypoglycaemic episodes will be induced using a glucose-insulin clamp. An insulin infusion will be commenced based on body surface area at 125 mU/m^2/min then titrated over 10 minutes to a maintenance rate of 40mU/m^2/min and will remain constant for 60 mins. The rate of a concurrently run infusion of glucose (25%) will be varied to maintain blood glucose at the desired level. During this time blood glucose level will be monitored every 5 mins and every 15 mins following the hypoglycae
Antecedent hypoglycaemic episodes will be induced using a glucose-insulin clamp. An insulin infusion will be commenced based on body surface area at 125 mU/m^2/min then titrated over 10 minutes to a maintenance rate of 40mU/m^2/min and will remain constant for 60 mins. The rate of a concurrently run infusion of glucose (25%) will be varied to maintain blood glucose at the desired level. During this time blood glucose level will be monitored every 5 mins and every 15 mins following the hypoglycaemic episode. This will be repeated 4 times on the antecedent hypoglycaemic visit. Whereas during the euglycaemic visit there will only be one induced hypoglycaemic episode. Each visit will last approximately 27 hours and will take place at least 6 weeks apart.
Sponsors
Associate Professor Adam Deane
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy lean (BMI 18-30) young men aged 18-35
Exclusion criteria
Exclusion criteria will comprise: *Radiation exposure for research purposes in the past 12 months; *History of diabetes; *HbA1c >6.0%; *Impaired renal function; *Creatinine clearance <100 ml/min; *Hb <130 g/L *Taking medication that are known to effect gastrointestinal motility; *Taking medication effecting blood glucose; *Previous surgery on the stomach or small intestine; *History of autonomic neuropathy; *Smoking >10 cigarettes per day; *Alcohol >20g per day; *History of cardiac disease ; *History of cardiac arrhythmias; *ECG abnormalities; *Because of concerns of cumulative life time exposure to radiation, we will directly screen all volunteers as to their previous radiation exposure, and will exclude any volunteer who has received 3 or more examinations using a computerized tomogram and/or 10 or more examinations using standard x-rays. *Previous surgery on the autonomic nervous system (eg sympathectomy) *Previous surgery on the adrenal glands *History of seizures or seizure disorders *History of migranes
Outcome results
None listed