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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Tadalafil

Intervention Type DRUG

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

Tadalafil

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

Group Type ACTIVE_COMPARATOR

Tadalafil

Intervention Type DRUG

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

Interventions

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Tadalafil

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

Intervention Type DRUG

Other Intervention Names

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Cialis

Eligibility Criteria

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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 5 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 \> 7%, ref value 3.5-5.3%)
2. Patients on glitazones, insulin, beta-blockers, ACE-inhibitors and corticosteroids

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per-Anders Jansson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region of Västra Götaland, Sahlgrenska University Hospital/Sahlgrenska University at University of Göteborg, Dept of Molecular and Clinical Medicine, SE 413 45 Göteborg, Sweden