NCT01238224

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 12, 2020

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

October 6, 2010

Last Update Submit

February 10, 2020

Conditions

Type 2 Diabetes

Keywords

Insulin resistancePhosphodiesterase-5 inhibitionMicrodialysisType 2 diabetesEndothelial dysfunctionOral hypoglycaemic agents

Outcome Measures

Primary Outcomes (1)

  • 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.

    Five hours after a mixed meal

Secondary Outcomes (1)

  • Vascular function and circulating biomarkers.

    Five hours after a mixed meal

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A single dose of placebo is administered 30 min before a mixed meal.

Drug: Tadalafil

Tadalafil

ACTIVE COMPARATOR

A single dose of tadalafil 20 mg is administered 30 min before a mixed meal.

Drug: Tadalafil

Interventions

TadalafilDRUG

This is an acute study. Tadalafil 20 mg administered prior to a meal

Also known as: Cialis
PlaceboTadalafil

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal state, defines as natural amenorrhea for at least 12 months.
  • Age; females 52-65 years, males: 40-65 years.
  • Type 2 diabetes based on fasting plasma glucose or 2-hr glucose after an OGTT.
  • Diabetes duration less than 5 years.

You may not qualify if:

  • 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 \> 7%, ref value 3.5-5.3%)
  • Patients on glitazones, insulin, beta-blockers, ACE-inhibitors and corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wallenberg Laboratory, Dept of Molecular and Clinical Medicine, Sahlgrenska University Hospital, Bruna stråket 16,

Gothenburg, SE 413 45, Sweden

Location

Related Publications (1)

  • Jansson PA, Murdolo G, Sjogren L, Nystrom B, Sjostrand M, Strindberg L, Lonnroth 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.

    PMID: 20535445BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2010

First Posted

November 10, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 12, 2020

Record last verified: 2015-06

Locations

SE(1)