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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
First received: May 25, 2007
Last updated: May 6, 2008
Last verified: May 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Placebo Comparator: 1
Placebo gel
Drug: Placebo
Placebo gel
Active Comparator: 2
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:

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

    1. Abdominal obesity (waist circumference > 94 cm for European men) and any two of the following criteria
    2. Triglycerides > 1.7 mmol/L or specific treatment for this
    3. HDL < 1.03 nmol/L or specific therapy for this
    4. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or treatment for this.
    5. Fasting plasma glucose ≥ 5.6 mmol/L (venous glucose ≥ 6.1 mmol/L) or previously diagnosed type 2 diabetes mellitus defined by: Fasting plasma glucose ≥ 7.8 mmol/L on two occasions, or random glucose ≥ 11.1 mmol/L and classic symptoms of type 2 diabetes
  3. Impaired glucose tolerance If the definition of the metabolic syndrome, as described above, is fulfilled but fasting plasma glucose ≤ 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)
  4. 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.
  5. Screening value of HbA1c <7.5 %
  6. Weight < 110 kg
  7. Body Mass Index (BMI) < 35
  8. Hematocrit < 50%
  9. Signed Written informed consent obtained -

Exclusion Criteria:

  1. Ongoing pharmacological treatment of type 2 diabetes except for metformin.
  2. Use of androgen therapy or anabolic steroids within 6 months of entry into the study.
  3. Known congestive heart failure, progressing angina pectoris or a history of myocardial infarction within the last 12 months.
  4. Known untreated pituitary disease.
  5. A history of significant renal or liver disease or any malignancy.
  6. Use of drugs interfering with androgens; spironolactone, Ketoconazol, corticosteroids, cimetidine, fentiazines, tricyclic antidepressants, anabolic steroids, 5-alfa reductase inhibitors, antiestrogens.
  7. Prostate Specific Antigen (PSA) > 4 ng/ml.
  8. Suspected malignancy after prostata palpation, unless biopsy shows the opposite.
  9. Malignant tumour of the mammary gland
  10. Ongoing micturition problem severely affecting patient's daily living as judged by the investigator.
  11. 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.
  12. Contagious blood disease.
  13. Known alcohol or drug abuse, or any condition associated with poor compliance.
  14. Participation in a clinical study during the last 90 days before start of treatment.
  15. Previous enrolment or randomisation in the present study -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Stefan Arver, MD, PhD +46858586876 stefan.arver@ki.se
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

No publications provided

Responsible Party: Stefan Arver Associate Prof, Sr Physician, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00479609     History of Changes
Other Study ID Numbers: ARTinMMS
Study First Received: May 25, 2007
Last Updated: May 6, 2008
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 25, 2014