The Microvascular Function of GLP-1 and Its Analogues

يمكن للمستخدمين المسجلين فقط ترجمة المقالات

الدخول التسجيل فى الموقع

يتم حفظ الارتباط في الحافظة

الحالةمنجز

الرعاة

Katarina Kos

المتعاونون

Diabetes UK

تجربة سريرية: NCT01677104

BioSeek: nct01677104

الكلمات الدالة

نبذة مختصرة

Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.

The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.

The study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.

تواريخ

آخر التحقق:	03/31/2017
تم الإرسال لأول مرة:	08/28/2012
تم إرسال التسجيل المقدر:	08/29/2012
أول نشر:	08/30/2012
تم إرسال آخر تحديث:	04/11/2017
آخر تحديث تم نشره:	04/12/2017
تاريخ بدء الدراسة الفعلي:	07/31/2012
تاريخ الإنجاز الأساسي المقدر:	06/30/2014
التاريخ المتوقع لانتهاء الدراسة:	06/30/2014

حالة أو مرض

Type 2 Diabetes

Obesity

التدخل / العلاج

Drug: GLP-1

Drug: Placebo

مرحلة

مجموعات الذراع

ذراع	التدخل / العلاج
Active Comparator: DPP-IV inhibitor Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues
Placebo Comparator: Placebo pill One placebo tablet before microinjection

معايير الأهلية

الأعمار المؤهلة للدراسة	18 Years إلى 18 Years
الأجناس المؤهلة للدراسة	All
يقبل المتطوعين الأصحاء	نعم
المعايير	Inclusion Criteria: - Lean BMI ≤ 25.0 kg/m2 - Obese BMI ≥30.0kg/m2 - Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months Exclusion Criteria: - cardiovascular disease - Raynaud's disease - current treatment with any anti-hypertensive - lipid lowering therapies - severe hepatic impairment - pregnancy and lactation - subjects with Type 2 diabetes on insulin therapy - subjects with Type 2 diabetes on sulphonylureas - subjects with Type 2 diabetes on incretin based therapies - subjects with Type 2 diabetes and peripheral vascular disease - subjects with Type 2 diabetes and history of advanced retinopathy - subjects with Type 2 diabetes and advanced nephropathy - subjects with Type 2 diabetes with uncontrolled diabetes (HbA1c > 8.5%)

النتيجة

مقاييس النتائج الأولية

1. skin blood flow [3 hours]

skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo