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The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Men receiving Nebido |
|
| 2 | Placebo Comparator | Men receiving Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebido (testosterone undecanoate) | Drug | Nebido (testosterone undecanoate) intramuscular 4 ml by scheme |
|
| Measure | Description | Time Frame |
|---|---|---|
| waist-to-hip ratio | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Svetlana Kalinchenko, PhD | Contact | +70951244301 | kalinchenko@list.ru | |
| Yuliya Tishova | Contact | +79032213276 | yulya_tishova@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Svetlana Kalinchenko, PhD | Scientific Center for Endocrinology, Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Centre for Endocrinology RAMS | Recruiting | Moscow | 117136 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38433502 | Derived | Tishova Y, Kalinchenko S, Mskhalaya G, Hackett G, Livingston M, Konig C, Strange R, Zitzmann M, Mann A, Maarouf A, Ramachandran S. Testosterone therapy reduces insulin resistance in men with adult-onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open-label phase. Diabetes Obes Metab. 2024 Jun;26(6):2147-2157. doi: 10.1111/dom.15520. Epub 2024 Mar 3. | |
| 38224135 |
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| Placebo | Drug | Placebo 4 mL intramuscular |
|
| Derived |
| Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2. |
| 20718771 | Derived | Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x. |
| 20524974 | Derived | Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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