Department of Medicine, Saint Görans Hospital, Stockholm, Sweden.
Eur J Endocrinol. 2012 Nov;167(5):697-703. doi: 10.1530/EJE-12-0484. Epub 2012 Sep 3.
The aim of this trial was to evaluate the effect on insulin sensitivity and body composition of combination therapy with GH and IGF1 in adults with GH deficiency (GHD) and diabetes.
DESIGN, PATIENTS AND METHODS: A 6-month randomised placebo-controlled pilot study. Fourteen adults with GHD and type 2 diabetes were included. All received rhGH (0.15 mg/day for 1 month and 0.3 mg/day for 5 months) and were randomised to rhIGF1 (15 μg/kg per day for 1 month and 30 μg/kg per day for 5 months) or placebo. Insulin sensitivity was evaluated with euglycaemic hyperinsulinaemic clamp and body composition by computed tomography of abdominal and thigh fat, as well as bioimpedance.
Twelve patients completed the study. They were overweight and obese; at baseline, insulin sensitivity (M-value) was low. IGF1 and IGF1 SDS increased in both groups, with the highest increase in the GH and IGF1 group. Positive changes in M-value by +1.4 mg/kg per min, in subcutaneous abdominal fat by -60.5 ml and in fat-free mass by +4.4% were seen in the GH and IGF1 group. Corresponding values in the GH and placebo-treated group were -1.5 mg/kg per min, +23 ml and -0.04% respectively (P=0.02, P=0.04 and P=0.03 for delta values between groups). No safety issues occurred.
Combined GH and IGF1 treatment resulted in positive, but rather small effects, and might be a treatment option in a few selected patients.
本试验旨在评估 GH 和 IGF1 联合治疗对 GH 缺乏（GHD）合并糖尿病成人胰岛素敏感性和身体成分的影响。
设计、患者和方法：这是一项为期 6 个月的随机安慰剂对照试验。共纳入 14 例 GHD 合并 2 型糖尿病成人。所有患者均接受 rhGH（第 1 个月 0.15mg/天，第 2-6 个月 0.3mg/天）治疗，并随机分为 rhIGF1（第 1 个月 15μg/kg/天，第 2-6 个月 30μg/kg/天）或安慰剂组。通过正葡萄糖高胰岛素钳夹试验评估胰岛素敏感性，通过腹部和大腿脂肪的计算机断层扫描以及生物电阻抗评估身体成分。
12 例患者完成了研究。他们超重和肥胖，基线时胰岛素敏感性（M 值）较低。两组 IGF1 和 IGF1 SDS 均升高，GH 和 IGF1 组升高最明显。GH 和 IGF1 组 M 值增加了+1.4mg/kg/min，腹部皮下脂肪减少了-60.5ml，去脂体重增加了+4.4%。GH 和安慰剂组相应值分别为-1.5mg/kg/min，+23ml 和-0.04%（两组间差值 P=0.02，P=0.04 和 P=0.03）。未发生安全性问题。
GH 和 IGF1 联合治疗可产生积极但较小的效果，可能是少数精选患者的治疗选择。
