Effect of Intranasal Insulin on LH Concentrations in Man
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- LH
研究概览
简要总结
Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones. Obesity and metabolic syndrome are also associated with HH. Research suggests that insulin in the brain may benefit the glands that release these hormones. During this study, subjects will spray a small amount of insulin into their nose.This will increase insulin concentrations in the brain. The purpose of this study is to find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in obese diabetic men with HH.
详细描述
Studies over the last few years have clearly established that at least 25% of men with type 2 diabetes have subnormal free testosterone (T) concentrations in association with inappropriately low leutinizing hormone (LH) and FSH (follicle stimulating hormone) concentrations. These patients thus suffer from hypogonadotrophic hypogonadism (HH). Obesity and metabolic syndrome are also associated with HH. Animal studies and in vitro data have shown that insulin action and insulin responsiveness in the brain are necessary for the maintenance of the functional integrity of the hypothalamo-hypophyseal-gonadal axis. Insulin concentrations can be increased in the brain by delivering insulin intranasally with vianase device. The aim of this project is to study the effect of one dose of intranasal insulin on release of LH in obese diabetic men with HH. 15 obese men with type 2 diabetes and low free T along with normal LH concentrations will be recruited for the study. The study will be carried out at the clinical center of Texas Tech (Odessa campus). There will be two study visits, each comprising of blood tests every 15 minutes over 6 hours. 40 IU of intranasal insulin or saline will be given after a baseline period of blood sampling of 2 hours. Student's t-test will be used to compare the change in LH concentrations after intranasal saline or insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males age 18 to 75 years
- •Obesity (BMI ≥30 kg/m2)
- •Type 2 diabetes
- •Hypogonadotropic hypogonadism defined as calculated free testosterone concentrations below 7 ng/dl along with normal or low LH concentrations
排除标准
- •HbA1c>8.5%
- •Use of preprandial insulin therapy
- •Use of testosterone currently or in the past 4 months
- •Use of over the counter health supplements which contain androgens
- •Use of corticosteroids or narcotics in the past 3 months
- •Coronary event or procedure(myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous twelve weeks
- •Type I Diabetes
- •Currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious or inflammatory condition
- •Hepatic disease (transaminase > 3 times normal) or cirrhosis
- •Renal impairment (defined as glomerular filtration rate<30)
- •HIV or Hepatitis C positive status
- •Any other life-threatening, non-cardiac disease
- •History of untreated severe obstructive sleep apnea(defined as apnea-hypopnea index ≥30)
- •currently suffering from symptomatic depression, with or without treatment
- •Use of an investigational agent or therapeutic regimen within 30 days of study
- •Participation in any other concurrent clinical trial
- •Pituitary tumor/damage/ other trophic hormone deficiency
研究组 & 干预措施
diabetes
All patient will receive insulin at one visit and saline at another visit
干预措施: intranasal insulin (Drug)
diabetes
All patient will receive insulin at one visit and saline at another visit
干预措施: placebo (intranasal saline) (Drug)
control
All patient will receive insulin at one visit and saline at another visit
干预措施: intranasal insulin (Drug)
control
All patient will receive insulin at one visit and saline at another visit
干预措施: placebo (intranasal saline) (Drug)
结局指标
主要结局
LH
时间窗: 4 hours
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
次要结局
未报告次要终点