Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes

Summary

Men with metabolic syndrome often have lower than normal testosterone levels and low testosterone levels have been suggested to predispose for development of type2 diabetes. The aim of the study is to evaluate if normalisation of serum testosterone levels in men with metabolic syndrome (Abdominal obesity, hypertension, dyslipidemia, insulin resistance and pre-diabetes or overt type diabetes)improves sensitivity to insulin and improves the signs of the metabolic syndrome

Conditions

• Metabolic Syndrome

Interventions

DRUG

Transdermal testosterone therapy

testosterone 1% hydroalcohol gel

DRUG

Placebo

Placebo gel

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Southern Hospital Stockholm

  collaborator UNKNOWN

• UroHealth Skövde

  collaborator UNKNOWN

• Universitätsklinikum MünsterInstitut für Reproduktionsmedizin

  collaborator UNKNOWN

• Krankenanstalt der Stadt Wien Rudolfstiftung

  collaborator UNKNOWN

• Medical University of Graz

  collaborator OTHER

• Krankenhaus der Stadt Wien Lainz

  collaborator UNKNOWN

• Medical University of Vienna

  collaborator OTHER

• Endokrinologikum Hamburg

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Urban Ekström, MD · Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2009-01-31

Completion

2009-04-30

Countries

• Sweden

Study Locations