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

NCT00479609 | Unknown Phase 3 DMC

• 1 other identifier: ARTinMMS
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insulin resistance; Glucose tolerance; Type 2 diabetes; Androgen sensitivity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity,

  q2 2007- q3 2008

Secondary Outcomes (1)

• Glucose tolerance, HbA1c levels, Abdominal obesity, prostate safety, Sexual function, Sleepiness, Urinary symptoms, Hypogonadal symptoms score

  Q 2 2007 - q 3 2008

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo

2

ACTIVE COMPARATOR

Transdermal testostrone therapy

Drug: Transdermal testosterone therapy

Interventions

Transdermal testosterone therapy DRUG

testosterone 1% hydroalcohol gel

2

Placebo DRUG

Placebo gel

1

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or treatment for this.
• 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
• 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)
• Screening value of HbA1c \<7.5 %
• Weight \< 110 kg
• Body Mass Index (BMI) \< 35
• Hematocrit \< 50%
• Signed Written informed consent obtained -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Southern Hospital Stockholm: collaborator
• UroHealth Skövde: collaborator
• Universitätsklinikum MünsterInstitut für Reproduktionsmedizin: collaborator
• Krankenanstalt der Stadt Wien Rudolfstiftung: collaborator
• Medical University of Graz: collaborator
• Krankenhaus der Stadt Wien Lainz: collaborator
• Medical University of Vienna: collaborator
• Endokrinologikum Hamburg: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, SE14186, Sweden

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Urban Ekström, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Arver, MD, PhD

CONTACT

+46858586876; stefan.arver@ki.se

Elin Zamore, RN

CONTACT

+46858580466; Elin.zamore@karolinska.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 7, 2008

Record last verified: 2008-05

Locations

SE (1)