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Does modulating the gut hormones, incretins, modify vascular function, thereby reducing the risk of vascular complications in insulin resistant individuals? - (duplicate) (duplicate) (duplicate) (duplicate) Do the gut hormones modify vascular function in obes

Phase 1
Conditions
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: 9.1Level: LLTClassification code 10029883Term: Obesity
Registration Number
EUCTR2009-013100-32-GB
Lead Sponsor
niversity of Exeter
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
15
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

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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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