The aim of the study is to explore whether we can detect diabetes-related changes in endothelial cells obtained by the ‘endothelial biopsy’ technique.
We are planning a clinical study in which we test the affects of diabetes on vascular endothelial function. To address molecular mechanisms, we will collect endothelial cells from a forearm cubital vein and assess levels of pro-oxidant enzymes, pro-inflammatory signaling molecules, and products of oxidant reactions.
This is a physiologic trial. This protocol study is designed to detect changes in endothelial biopsy specimens in subjects with and without type 2 diabetes mellitus. For this protocol study, there are two study visits: a screening visit and one testing visit. The primary outcome is the results of endothelial biopsy.
For healthy subjects:
Inclusion criteria:
· Age ≥ 18 years
Exclusion criteria:
· Age ≥ 65 years (our laboratory has documented age-associated impairment in endothelial function)
· Hypertension, defined as a prior physician diagnosis, or a blood pressure of ≥ 140/90 mm Hg
· Hypercholesterolemia, defined as a prior physician diagnosis, or a total cholesterol of ≥ 240 mg/dL
· Diabetes mellitus, defined as a prior physician diagnosis, or a serum fasting glucose of ≥ 126 mg/dL
· Pregnancy
· BMI ≥ 30 kg/m2
· Active use of cocaine, heroin, methamphetamines, or other illicit substance
· Alcohol intake in excess of 2 beverages per day
· Chronic inflammatory disorder such as collagen vascular disease, chronic hepatitis, malignant cancer, etc.
For diabetic subjects:
Inclusion criteria:
· Age ≥ 18 years
· Clinical diagnosis of type 2 diabetes mellitus
· Hgb A1C 7.0% or above
Exclusion criteria:
· Age ≥ 65 years (our laboratory has documented age-associated impairment in endothelial function)
· Hypertension, defined as a prior physician diagnosis, or a blood pressure of ≥ 140/90 mm Hg
· Hypercholesterolemia, defined as a prior physician diagnosis, or a total cholesterol of ≥ 240 mg/dL
· Pregnancy
· Active use of cocaine, heroin, methamphetamines, or other illicit substance
· Alcohol intake in excess of 2 beverages per day
· Chronic inflammatory disorder such as collagen vascular disease, chronic hepatitis, malignant cancer, etc.
Useful links: Consent Form