Obese (BMI equal or greater than 30) individuals at a high risk of diabetes, but without overt cardiovascular disease or taking oral hypoglycaemic, anti-hypetensive or lipid lowering therapies. Purpose of study is to examine whether the modulation of incretins (gut hormones) by the adminstration of Vildagliptin alters vascular function and thus surrogates markers of diabetic related vascular complications (nephropathy and macular oedema) in obese, non-diabetic individuals. MedDRA version: 9.1 L
Conditions
Interventions
Trade Name: Vildagliptin
Product Name: Vildagliptin
Product Code: SRP01033v
Pharmaceutical Form: Tablet
INN or Proposed INN: (S)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile
CA
Sponsors
University of Exeter
Royal Devon and Exeter NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Principal inclusion criteria: obesity (body mass index greater or equal to 30 m(2)/kg) and high risk of diabetes as defined by the Finnish Diabetes Risk Questionaire. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: diabetes, overt cardiovascular disease, Raynauds disease, renal impairment, hepatic impairment (aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal), hypersensitivity to Vildagliptin or any of its excipents (eg anhydrous lactose) and current treatment with any anti-hypertensive, oral hypoglycaemic or lipid lowering therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of this research is determine whether increasing the levels of the gut hormones (incretins) by preventing their breakdown with the sugar lowering medication, Vildagliptin, improves 1) the function of both large and small blood vessels and 2) whether any observed improvements in blood vessel function translate to clinical benefits in the kidneys and the eyes in obese individuals. ;Secondary Objective: ;Primary end point(s): Capillary pressure Macular (fovea) thickness albumin excretion rate albumin / creatinine ratio Microvascular filtration capacity Maximum Hyperaemia Skin microvascular endothelial (in)dependent function Peak reactive hyperaemia Wave intensity analysis Pulse wave velocity Arterial endothelial (in)dependent function | — |
Countries
United Kingdom
Outcome results
None listed