Hypogonadism Type 2 Diabetes Cardiovascular risk
Conditions
Interventions
Trade Name: Nebido
Product Name: Nebido
Product Code: not applicable
Pharmaceutical Form: Injection
INN or Proposed INN: Testosterone Undecanoate
Current Sponsor code: 6232 6B1658
Other descriptive n
Sponsors
Research and Development department
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men with age >18 years 2. Type 2 Diabetes mellitus 3. HbA1C >7% =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent 2. Polycythaemia/ Haematocrit of >0.52 3. Abnormal prostrate digital rectal examination( palpable nodule/s) or severe prostratism or elevated PSA 4. History of prostrate cancer or breast cancer 5. Patient is enrolled in another experimental trial which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial 6. Patients with significant intercurrent disease like severe heart failure, kidney disease on dialysis, psychiatric illness or any other co-morbidities making them unable to attend the scheduled visits of the trial 7. History of alcohol abuse or any drug abuse in the past 2 years 8. Current use of antiandrogens, glucocorticoids ( except where used as replacement therapy), long acting opioid analgaesics( eg., methadone, buprenorphine), oestrogens, CYP3A4 inducers( eg., barbiturates) CYP3A4 inhibitors (eg., HIV antivirals, amiodarone, ketaconazole, ciprofloxacin, azithromycin etc) 9. Men seeking to father a child and have not yet completed the family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to find out the effect of adding testosterone to the standard diabetes treatment on glucose control. The primary outcome of the study will be HbA1C ( a blood test which looks at the average blood glucose control in patients with diabetes)and fasting plasma blood sugar levels. ;Secondary Objective: To compare the impact of testosterone therapy on I. Body composition ( measuring the body fat and lean muscle mass) a) Waist circumference and waist hip ratio b) Body mass index c) Percentage body fat (by Tanita body fat analyzer) d) Body composition using DEXA scan II. Insulin resistance a) Homa – IR (Homeostatic Model of Assessment of Insulin Resistance) in patients not on insulin (three blood samples for fasting insulin samples taken 5 minutes apart with fasting glucose) III. Lipid Profile ( cholesterol and other fat in blood) Fasting lipid profile (total cholesterol, LDL Cholesterol, HDL- Cholesterol, Triglycerides, Lipoprotein a and ApoE) IV. Inflammation hsCRP, IL-6, IL6 Soluble receptor, Adiponectin, leptin, TNF alpha, IL- 10, IL-1beta, ICAM – 1, VCAM -1 and AGEs (advance glycation end products). We also intend to store blood at -70oC for later analysis. V. Macrophage function: ( function of the scavenger cell in the blood which play a;Primary end point(s): HbA1c ;Timepoint(s) of evaluation of this end point: 0,12,24,36,52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare the impact of testosterone therapy on I. Body composition ( measuring the body fat and lean muscle mass) a) Waist circumference and waist hip ratio b) Body mass index c) Percentage body fat (by Tanita body fat analyzer) d) Body composition using DEXA scan II. Insulin resistance a) Homa – IR (Homeostatic Model of Assessment of Insulin Resistance) in patients not on insulin (three blood samples for fasting insulin samples taken 5 minutes apart with fasting glucose) III. Lipid Profile ( cholesterol and other fat in blood) Fasting lipid profile (total cholesterol, LDL Cholesterol, HDL- Cholesterol, Triglycerides, Lipoprotein a and ApoE) IV. Inflammation hsCRP, IL-6, IL6 Soluble receptor, Adiponectin, leptin, TNF alpha, IL- 10, IL-1beta, ICAM – 1, VCAM -1 and AGEs (advance glycation end products). We also intend to store blood at -70oC for later analysis. V. Macrophage function: ( function of the scavenger cell in the blood which play a inportant role in the development of plaque in the arteries causing heart disease) -Monocyte RNA: qPCR on specific genes involved in lipid, cholesterol, glucose metabolism and inflammation -Primary cell culture of macrophages for further assessment of these pathways – effect of exogenous testosterone and LXR agonists and antagonists on gene expression (qPCR) and protein level (Western blotting with densitometry) VI. Blood pressure After rest, 2 readings 5 minutes apart. 24 hr BP monitor VII. Renal(kidney)and Liver Function Urinary microalbumin, serum urea, creatinine and eGFR. Standard liver function tests (ALT, AST, alkaline phosphatase and gamma GT). VIII. Carotid Intima-Media Thickness ( measuring the thickness of carotid artery) (using Sonosite Portable Ultrasound device) IX. DNA collection: ( optional) ( looking at the genetic code of a cell) To look at androgen-receptor polymorphisms and its association with the above variables X. Safety | — |
Countries
United Kingdom
Contacts
Public ContactMichael Bramall
Research & Development Dept. Barnsley Hospital NHSFT
Outcome results
None listed