Hypogonadotropic Hypogonadism in Obese Young Males
Clomiphene
+ Placebo
Enfermedades del Sistema Endocrino
+ Trastornos Gonadales
+ Hipogonadismo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2019
Fecha en la que se inscribió al primer participante.The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:- 1. testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo. 2. insulin resistance: Investigators will measure insulin and glucose levels in the blood. 3. inflammation: Investigators will measure proteins that induce inflammation.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 9 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 30 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Males * Age 18-30 years inclusive will be recruited. A total of 90 males will be recruited:- * 30 obese males (defined as BMI ≥30 kg/m2) with HH, * 30 obese males with normal FT concentrations and * 30 lean males (defined as BMI \<25 kg/m2) with normal FT concentrations. Exclusion Criteria: * Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months * Hematocrit \> 50% * Congestive heart failure * currently suffering from depression * type 1 diabetes * Hepatic disease (transaminase \> 3 times normal) or cirrhosis * Renal impairment (eGFR\<30 ml/min/1.73m2) * HIV or Hepatitis C positive status * Participation in any other concurrent clinical trial * currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación