Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
研究概览
简要总结
Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.
详细描述
To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of < 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
- •Subjects who are at their usual weight (weight stable for at least 1 year)
- •Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).
排除标准
- •Possible confounders on body weight and insulin resistance
- •Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
- •Subjects who exercise > 30 minutes/day, 3 times a week.
- •Heavy alcohol drinkers (> 2 drinks/ day).
- •Subjects with medical diagnosis including diabetes, heart disease, and cancer.
- •Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).
研究组 & 干预措施
1
Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose.
干预措施: Hydrocortisone (Drug)
2
isocaloric diet
干预措施: Isocaloric Diet (Dietary Supplement)
结局指标
主要结局
Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
时间窗: After 4 months on each dose
次要结局
- Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy(After 4-months on each dose)