Effect of treatment with testosterone in diabetic patients (Type 1) with hypogonadism.

Phase 1

• Conditions: Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-000291-42-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Men older than or equal to 18.
2. Submit a diagnosis of diabetes mellitus type 1 and hypogonadotropic hypogonadism, defined as:
? Levels of total testosterone <8nmol / L(2.3 ng/mL), or total testosterone levels between 8 and 12 nmol / L (2.3-3.5 ng/mL)and calculated free testosterone <225 pmol / L (65 pg / mL).
? Determination of LH below 8.6 mU / mL and / or FSH lower than 14.2 IU / L.
3. Being able to provide informed consent before randomization and agree to abide by the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. Existence of chronic debilitating disease such as kidney failure, cirrhosis, HIV, COPD, heart failure, ischemic heart disease.
2. Patients with hypergonadotropic hypogonadism.
3. Patients diagnosed with panhypopituitarism.
4. Patients with hypogonadotropic hypogonadism secondary to pituitary tumor or empty sella.
5. Patients with hypogonadotropic hypogonadism secondary to hyperprolactinemia.
6. Patients with contraindications to the administration of testosterone: elevated PSA, breast carcinoma, prostate carcinoma, liver tumors
7. Patients previously treated with testosterona
8. Patients with allergy to testosterone and/or excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Analyze changes in the international index of erectile dysfunction after 22 weeks of treatment with testosterone undecanoate in patients with DM1 and hypogonadotropic hypogonadism.;Primary end point(s): Changing values of eGDR after 6, 16 and 22 weeks of treatment with testosterone undecanoate / placebo.;Timepoint(s) of evaluation of this end point: 22 weeks;Main Objective: Evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on insulin sensitivity, measured by eGDR (estimated Glucose Disposal Rate) and evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on the control anthropometric parameters glycemic blood pressure and lipid profile.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in glycemic control (HbA1c and FPG), anthropometric parameters (BMI, hip circumference, waist circumference), blood pressure and lipid profile.<br> Score on the questionnaire of erectile dysfunction.;Timepoint(s) of evaluation of this end point: 22 weeks