Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
1 other identifier
interventional
43
1 country
1
Brief Summary
A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM. Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance. Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 14, 2013
November 1, 2013
1.2 years
March 20, 2012
November 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Lean body mass
Accessed by DXA scanning
approximately three years
Secondary Outcomes (8)
Insulin sensitivity
three years
Regional body composition and liver fat
three years
Glucose and lipid oxidation
three years
Myostatin and satellite cells
8 years
Inflammation
8 years
- +3 more secondary outcomes
Study Arms (2)
Testim
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORPlacebo for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male gender age 50-70
- Bioavailable testosterone \< 7,3 nmol/L
- Metformin treatment of T2DM for 3 months or more
You may not qualify if:
- HbA1c \> 9,0 %, BMI \> 40 kg/m2, Haematocrit \> 50%,
- Known malignant disease, PSA \> 3 ug/L, Nycturia \> 3 times,
- Abnormal routine blood samples,
- Severe hypertension,
- Significant EKG-changes,
- Wish of parenthood,
- Active mental illness,
- former or present abuse,
- Severe illness of heart-, lung- or kidney,
- Primary or secondary hypogonadism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marianne Andersenlead
- Odense University Hospitalcollaborator
Study Sites (1)
Department of Endocrinology, Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.
PMID: 28168203DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Andersen, MD, ph.d.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, ph.d.
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2013
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11