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The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.
There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Experimental | Testosterone injections- 200mg- every 2 weeks |
|
| Placebo | Placebo Comparator | Normal saline injections- every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Sustanon- 200mg intramuscular testosterone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population | 6 months | |
| The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Jones, BSc MD FRCP | Barnsley Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnsley Hospital NHS Foundation Trust | Barnsley | South Yorkshire | S75 2EP | United Kingdom |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 0.9% saline |
| Drug |
Saline intramuscular injection every two weeks |
|
| The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage, | 6 months |
| urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population. | 6 months |
| The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone. | 6 months |
| D009750 | Nutritional and Metabolic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |