Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
研究概览
简要总结
Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.
The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.
详细描述
With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.
Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.
The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.
Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)
- •Hemoglobin > 7,3 mmol/L
- •Negative human chorionic gonadotropin (hCG) urine test
- •Females of reproductive age: use of safe contraception
排除标准
- •Treatment for cardiovascular disease
- •Treatment with antipsychotic medication
- •Treatment for thyroid disease
- •Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
- •Prior allergic reactions to the study medicine
研究组 & 干预措施
Pasireotide75
75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
干预措施: Pasireotide 0.3 MG/ML (Drug)
Pasireotide75
75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
干预措施: Meal tolerance test (MTT) (Diagnostic Test)
Pasireotide150
150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
干预措施: Pasireotide 0.3 MG/ML (Drug)
Pasireotide150
150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
干预措施: Meal tolerance test (MTT) (Diagnostic Test)
结局指标
主要结局
Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)
时间窗: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion
Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (\>7.8 mmol/L) and the hypoglycemic (\<3.9 mmol/L) range
次要结局
- Serum insulin levels(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
- Blood pressure(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
- Plasma GLP-1 levels(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
- Heart rate(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
- Serum C-peptide levels(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
- Plasma glucagon levels(From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion)
研究者
Caroline Christfort Øhrstrøm
MD, ph.d. student
Zealand University Hospital