A Phase 1 interventional study of Tadalafil in Type 2 Diabetes, sponsored by Vastra Gotaland Region. Terminated at 1 site in Sweden. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Vastra Gotaland Region · Phase 1, Interventional, and Treatment
An increase of blood flow and capillary permeability decrease the impact of an endothelial barrier for glucose and insulin allowing them to reach their target cells in peripheral insulin sensitive organ in the human body. It is well known that insulin-resistant type 2 diabetes patients have an impaired blood flow in skeletal muscle and it is therefore important to elucidate means to reverse this metabolic defect.
The investigators have in a recently published study in type 2 diabetes patients used a drug against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several vascular territories, to increase muscle blood flow in type 2 diabetes patients who were studied after fasting overnight.
The aim of this study is to test the hypothesis that tadalafil, compared to placebo, increases muscle glucose uptake and lowers blood glucose following a mixed meal served to type 2 diabetes patients.
An increase of blood flow and capillary permeability decrease the impact of an endothelial barrier for glucose and insulin allowing them to reach their target cells in peripheral insulin sensitive organ in the human body. It is well known that insulin-resistant type 2 diabetes patients have an impaired blood flow in skeletal muscle and it is therefore important to elucidate means to reverse this metabolic defect.
The investigators have in a recently published study in type 2 diabetes patients used a drug against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several vascular territories, to increase muscle blood flow in type 2 diabetes patients who were studied after fasting overnight. In fact, the investigators observed that tadalafil compared to placebo increased glucose uptake in muscle in parallel with an augmented capillary recruitment in muscle. This was the first publication to show that the pharmacological principle to inhibit the enzyme phosphodiesterase-5 (PDE-5) may mediate an increased muscle glucose uptake and, hence, may be a novel strategy to lower blood glucose in type 2 diabetes patients.
The aim of this study is to test the hypothesis that tadalafil, compared to placebo, increases muscle glucose uptake and lowers blood glucose following a mixed meal served to type 2 diabetes patients.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single dose of placebo is administered 30 min before a mixed meal.
Drug: Tadalafil
A single dose of tadalafil 20 mg is administered 30 min before a mixed meal.
Drug: Tadalafil
This is an acute study. Tadalafil 20 mg administered prior to a meal
Also known as: Cialis
Capillary recruitment, muscle glucose uptake and circulating glucose levels following a meal
Capillary recruitment and glucose uptake in forearm muscle as well as circulating glucose levels following acute administration of tadalafil or placebo in type 2 diabetes patients.
Time frame: Five hours after a mixed meal
Vascular function and circulating biomarkers.
Arterial stiffness as measured by pulse wave velocity and circulating concentrations of metabolic variables
Time frame: Five hours after a mixed meal
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Vastra Gotaland Region