Assessing risk of fluctuating lipid levels compared to constant hyperlipidaemia during constant hyperglycaemic state on endothelial function and oxidative stress parameters in type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This study includes one screening visit and two procedural visits. There will be a one week break between visit 2 and visit 3. We expect he or she would be in the study for 3-4 weeks in total.
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetes arm: 1. Aged 30 - 65 years 2. BMI 27 - 40 kg/m² 3. History of T2DM on diet with or without metformin Control arm 1. Aged 30 - 65 years 2. BMI 27 - 40 kg/m²
Exclusion criteria
Exclusion criteria: Diabetes arm: 1. Current smoking 2. Pregnancy/breastfeeding/trying to conceive 3. Participants on anti-diabetes medications except metformin 4. Participants on beta blocker/ thiazide diuretics 5. History of chronic kidney disease stage 3, ALT >3x upper limit of normal and active thyroid disease 6. History of recent cardiovascular event in last 12 weeks 7. History of coagulation disorders 8. History of bronchial asthma 9. History of allergy to insulin, soy oil, purified egg (intralipid) 10. History of taking lipid lowering agents within last 2 weeks 11. Unwilling to be informed to their GP about their participation Control arm: 1. Current smoking 2. Pregnancy/breastfeeding/trying to conceive 3. History of chronic kidney disease stage 3, ALT >3x upper limit of normal and active thyroid disease 4. History of recent cardiovascular event in last 12 weeks 5. History of coagulation disorders 6. History of bronchial asthma 7. History of diabetes mellitus 8. Participants on beta-blockers or thiazide diuretics 9. History of allergy to insulin, soy oil, purified egg (intralipid) 10. History of taking lipid lowering agents within last 4 weeks 11. Unwilling to be informed to their GP about their participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Beta cell function assessed by insulin measurements taken at fasting and every 10 min from T-30 to T0 and T340 to T360, and hourly during the whole procedure 2. Oxidative stress markers measured using blood samples drawn during visit 2 and 3 before, at the end of 2 h, 4 h and 6 h of the fatty substance infusion and will be centrifuged followed by analysis using the flow cytometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet activation/inhibition measured using blood samples drawn during visit 2 and 3 before, at the end of 2 h, 4 h and 6 h of the lipid infusion and will be centrifuged followed by analysis using the flow cytometer | — |
Countries
United Kingdom
Outcome results
None listed