drugset / Trial / NCT01127659
Testosterone Replacement in Men With Diabetes and Obesity
Phase 4
Completed
137 enrolled
University at Buffalo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.
Timeline
- Start
- 2010-05
- Primary completion
- 2015-03
- Completion
- 2015-11
Publications
- Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Sandhu S, Dandona P. Testosterone Increases the Expression and Phosphorylation of AMP Kinase alpha in Men With Hypogonadism and Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1169-75. doi: 10.1210/clinem/dgz288.
- Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Dandona P. Effect of Testosterone on FGF2, MRF4, and Myostatin in Hypogonadotropic Hypogonadism: Relevance to Muscle Growth. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2094-2102. doi: 10.1210/jc.2018-01832.
- Dhindsa S, Ghanim H, Batra M, Kuhadiya ND, Abuaysheh S, Sandhu S, Green K, Makdissi A, Hejna J, Chaudhuri A, Punyanitya M, Dandona P. Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes. Diabetes Care. 2016 Jan;39(1):82-91. doi: 10.2337/dc15-1518. Epub 2015 Nov 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Testosterone | Small molecule | 250 mg | Other |