title: Testosterone undecanoate improves lipid profile in patients with type 1 diabetes and hypogonadotrophic hypogonadism.
abstract: Testosterone deficiency (Td) has been associated with the metabolic syndrome. Few studies have evaluated this condition in type 1 diabetes (T1D). The primary aim of this study was to evaluate the effectiveness of testosterone undecanoate (TU) on insulin sensitivity, glycemic control, anthropometric parameters, blood pressure and lipid profile in patients with Td and T1D. We performed a randomized placebo-controlled multicenter study.
  
  
  METHODS
  a) age ≥ 18 years; b) autoimmune diabetes; c) Td (total testosterone <10 nmol/L or calculated free testosterone <225 pmol/L and low/normal LH; d) ability to sign informed consent; e) comply with the study protocol.
  
  
  METHODS
  a) pituitary tumor, empty sella, hyperprolactinemia, panhypopituitarism or secondary hypogonadism; b) contraindications for treatment with testosterone undecanoate (TU); c) patients who did not agree to sign their informed consent. Six patients were randomly assigned to testosterone undecanoate (TU) treatment and 7 to placebo with the following dosing schedule: baseline, 6 weeks and 16 weeks. Blood test, anthropometric parameters, blood pressure and insulin sensitivity were determined at baseline, 6, 16 and 22 weeks. No differences were observed regarding insulin sensitivity, HbA1cor basal glucose, anthropometric parameters or blood pressure. At 22 weeks, the decrease in total cholesterol was 37.4 ± 27.5 mg/dL in the TU group compared with an increase of 13.2 ± 17.8 mg/dL in the placebo group (P<0.005), and LDL cholesterol concentration decreased 30.2 ± 22.1 mg/dL, compared with an increase of 10.5 ± 13.4 mg/dL in the placebo group (P=0.004). We conclude that treatment with TU in patients with T1D and Td improves lipid profile, with no effects on metabolic control or anthropometric parameters.
authors.affiliation: Department of Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Chillarón
authors.forename: Mercè
authors.initials: M
authors.lastname: Fernández-Miró
authors.forename: Mercè
authors.initials: M
authors.lastname: Albareda
authors.forename: Sara
authors.initials: S
authors.lastname: Fontserè
authors.forename: Cristina
authors.initials: C
authors.lastname: Colom
authors.forename: Lluís
authors.initials: L
authors.lastname: Vila
authors.forename: Juan
authors.initials: J
authors.lastname: Pedro-Botet
authors.forename: Juana A
authors.initials: JA
authors.lastname: Flores Le-Roux
mesh_terms: D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D050356:Lipid Metabolism / Q000187:drug effects; D008055:Lipids / Q000097:blood*; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000150:complications; D008875:Middle Aged; D013030:Spain; D013739:Testosterone / Q000031:analogs & derivatives* / Q000097:blood / Q000172:deficiency / Q000627:therapeutic use
chemical_list: D008055:Lipids; D013739:Testosterone; C010792:testosterone undecanoate