Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Vastra Gotaland Region.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT01238224
First received: October 6, 2010
Last updated: November 9, 2010
Last verified: November 2010

October 6, 2010
November 9, 2010
November 2009
December 2011   (final data collection date for primary outcome measure)
Capillary recruitment, muscle glucose uptake and circulating glucose levels following a meal [ Time Frame: Five hours after a mixed meal ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01238224 on ClinicalTrials.gov Archive Site
Vascular function and circulating biomarkers. [ Time Frame: Five hours after a mixed meal ] [ Designated as safety issue: No ]
Arterial stiffness as measured by pulse wave velocity and circulating concentrations of metabolic variables
Same as current
Not Provided
Not Provided
 
Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes
The Effect of Selective PDE-5 Inhibition on Capillary Recruitment, Glucose Uptake and Endothelial Function Following a Mixed Meal in Patients With 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Tadalafil
This is an acute study. Tadalafil 20 mg administered prior to a meal
Not Provided
Jansson PA, Murdolo G, Sjögren L, Nyström B, Sjöstrand M, Strindberg L, Lönnroth P. Tadalafil increases muscle capillary recruitment and forearm glucose uptake in women with type 2 diabetes. Diabetologia. 2010 Oct;53(10):2205-8. doi: 10.1007/s00125-010-1819-4. Epub 2010 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Postmenopausal state, defines as natural amenorrhea for at least 12 months.
  2. Age; females 52-65 years, males: 40-65 years.
  3. Type 2 diabetes based on fasting plasma glucose or 2-hr glucose after an OGTT.
  4. Diabetes duration less than 3 years.

Exclusion Criteria:

  1. Patients with concurrent use of nitrates or NO donors, history of heart or cerebrovascular disease, cardiac failure (stages NYHA II-IV), uncontrolled hypertension (> 160/100 mm Hg), significant diabetic complications, and inadequate glycemic control (HbA1c > 6.5%, ref value 3.5-5.3%)
  2. Patients on glitazones, insulin, beta-blockers, ACE-inhibitors, angiotensin II subtype 1 receptor blockers and corticosteroids
Both
40 Years to 65 Years
No
Contact: Per-Anders Jansson, MD, PhD +46 31 3421000 per-anders.jansson@medic.gu.se
Sweden
 
NCT01238224
2007-003921-25
No
Per-Anders Jansson, MD, PhD, Region of Västra Götaland, Sahlgrenska University Hospital & Sahlgrenska Academy at Göteborg University
Vastra Gotaland Region
Not Provided
Principal Investigator: Per-Anders Jansson, MD, PhD Region of Västra Götaland, Sahlgrenska University Hospital/Sahlgrenska University at University of Göteborg, Dept of Molecular and Clinical Medicine, SE 413 45 Göteborg, Sweden
Vastra Gotaland Region
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP