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

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

This study is currently recruiting participants.
Verified by Karolinska Institutet, May 2008

Sponsors and Collaborators: Karolinska Institutet
Karolinska University Hospital
Southern Hospital Stockholm
UroHealth Skövde
Universitätsklinikum MünsterInstitut für Reproduktionsmedizin
Krankenanstalt der Stadt Wien Rudolfstiftung
Medical University of Graz
Krankenhaus der Stadt Wien Lainz
Medizinische Universität Wien
Endokrinologikum Hamburg
Charite University, Berlin, Germany

Information provided by: Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00479609

Purpose
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

Condition Intervention Phase
Metabolic Syndrome
Drug: Transdermal testosterone therapy
Drug: Placebo
Phase III

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Dextrose

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title: A Randomised Placebo Controlled Study of Transdermal Testosterone Therapy to Investigate the Efficacy and Safety in Men With Abdominal Obesity, Low Testosterone Levels and Early Stages of the Metabolic Cluster Syndrome.
Further study details as provided by Karolinska Institutet:


Primary Outcome Measures:
Insulin sensitivity, [ Time Frame: q2 2007- q3 2008 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:
Glucose tolerance, HbA1c levels, Abdominal obesity, prostate safety, Sexual function, Sleepiness, Urinary symptoms, Hypogonadal symptoms score [ Time Frame: Q 2 2007 - q 3 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 176
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator
Placebo gel Drug: Placebo
Placebo gel
2: Active Comparator
Transdermal testostrone therapy Drug: Transdermal testosterone therapy
testosterone 1% hydroalcohol gel

Show Detailed Description

Eligibility
Ages Eligible for Study: 30 Years to 70 Years
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Male 30 to 70 years (inclusive)
Metabolic syndrome defined according to the International Diabetes Foundation (IDF):

Abdominal obesity (waist circumference > 94 cm for European men) and any two of the following criteria
Triglycerides > 1.7 mmol/L or specific treatment for this
HDL < 1.03 nmol/L or specific therapy for this
Systolic blood pressure &#8805; 130 mmHg or diastolic blood pressure &#8805; 85 mmHg or treatment for this.
Fasting plasma glucose &#8805; 5.6 mmol/L (venous glucose &#8805; 6.1 mmol/L) or previously diagnosed type 2 diabetes mellitus defined by: Fasting plasma glucose &#8805; 7.8 mmol/L on two occasions, or random glucose &#8805; 11.1 mmol/L and classic symptoms of type 2 diabetes
Impaired glucose tolerance If the definition of the metabolic syndrome, as described above, is fulfilled but fasting plasma glucose &#8804; 5.6 mmol/L (fasting venous glucose is < 6.1 mmol/L) the result of an oral glucose tolerance test must be classified as reduced glucose tolerance with a venous blood glucose 7.8 - 11.1 mmol/L or higher 120 min after intake of 75 g of glucose in a water solution (2h OGTT) (www.diabetes.org/main/info/pre-diabetes.jsp)
Hypogonadism, S-Testosterone <12 nmol/L taken at 7:00-10:00 a.m. Sample taken less than 2 months before inclusion in the study.
Screening value of HbA1c <7.5 %
Weight < 110 kg
Body Mass Index (BMI) < 35
Hematocrit < 50%
Signed Written informed consent obtained -
Exclusion Criteria:

Ongoing pharmacological treatment of type 2 diabetes except for metformin.
Use of androgen therapy or anabolic steroids within 6 months of entry into the study.
Known congestive heart failure, progressing angina pectoris or a history of myocardial infarction within the last 12 months.
Known untreated pituitary disease.
A history of significant renal or liver disease or any malignancy.
Use of drugs interfering with androgens; spironolactone, Ketoconazol, corticosteroids, cimetidine, fentiazines, tricyclic antidepressants, anabolic steroids, 5-alfa reductase inhibitors, antiestrogens.
Prostate Specific Antigen (PSA) > 4 ng/ml.
Suspected malignancy after prostata palpation, unless biopsy shows the opposite.
Malignant tumour of the mammary gland
Ongoing micturition problem severely affecting patient's daily living as judged by the investigator.
Any contraindication for treatment with testosterone 1% hydroalchol gel according to the labelling as well as known or suspected allergy to the specific product used in the study.
Contagious blood disease.
Known alcohol or drug abuse, or any condition associated with poor compliance.
Participation in a clinical study during the last 90 days before start of treatment.
Previous enrolment or randomisation in the present study -
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00479609

Contacts


Contact: Stefan Arver, MD, PhD +46858586876

Contact: Elin Zamore, RN +46858580466 Elin.zamore@karolinska.se

Locations

Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, SE14186
Sub-Investigator: Åke Pousette, MD, PhD

Sponsors and Collaborators

Karolinska Institutet

Karolinska University Hospital

Southern Hospital Stockholm

UroHealth Skövde

Universitätsklinikum MünsterInstitut für Reproduktionsmedizin

Krankenanstalt der Stadt Wien Rudolfstiftung

Medical University of Graz

Krankenhaus der Stadt Wien Lainz

Medizinische Universität Wien

Endokrinologikum Hamburg

Charite University, Berlin, Germany

Investigators

Principal Investigator: Urban Ekström, MD Karolinska University Hospital

More Information


Responsible Party: Karolinska Institutet ( Stefan Arver Associate Prof, Sr Physician )
Study ID Numbers: ARTinMMS
First Received: May 25, 2007
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00479609
Health Authority: Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Keywords provided by Karolinska Institutet:
Insulin resistance
Glucose tolerance
Type 2 diabetes
Androgen sensitivity


Study placed in the following topic categories:
Obesity
Testosterone
Diabetes Mellitus, Type 2
Diabetes Mellitus
Methyltestosterone
Insulin Resistance
Insulin
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Anabolic Agents
Pathologic Processes
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on December 09, 2008