Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glucose tolerance
研究概览
简要总结
The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.
Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.
The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.
The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.
Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
- •BMI > 25 kg/m
- •Waist/hip ratio > 0.95
排除标准
- •Proliferative diabetic retinopathy.
- •Macro-albuminuri and/or serum creatinine >150mmol/L
- •Known ischemic heart disease, previous stroke or claudicatio intermittence.
- •Known malignancy.
- •Other hormonal therapy.
研究组 & 干预措施
Recombinant human growth hormone
The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
干预措施: recombinant human growth hormone (Drug)
Placebo
干预措施: recombinant human growth hormone (Drug)
结局指标
主要结局
Glucose tolerance
时间窗: Baseline, 3, 6 and 12 months
次要结局
- Fasting plasma glucose, serum insulin, HbA1c(Basline, 1,2,3,6,9 and 12 months)
- Sleep architecture(Baseline and 12 months)
- Visceral adipose tissue(Baseline and 12 months)
- Progress of atherosclerosis (IMT)(Baseline and 12 months)