Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Glucose
研究概览
简要总结
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).
详细描述
The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.
The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intervention group
- •RYGB-operated ≥ 18 months prior to inclusion
- •History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
- •HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
- •Weight change < ±3 kg for >3 months at time of inclusion
- •Control group A
- •No history of diabetes
- •HbA1c <48 mmol/mol at time of inclusion
- •Fasting plasma glucose < 7.0 mmol/L at time of inclusion
- •Weight change < ±3 kg for >3 months at time of inclusion Control group B
- •Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
- •Weight change < ±3 kg for >3 months at time of inclusion
排除标准
- •Pregnancy or breastfeeding
- •Haemoglobin < 6.5 mmol/L at time of inclusion
- •Fasting plasma glucose > 10.0 mmol/L at time of inclusion
- •Prior cholecystectomy
- •Chronic or tendency to diarrhoea
研究组 & 干预措施
3.75 mg Colesevelam in 8 weeks
干预措施: Colesevelam (Drug)
结局指标
主要结局
Glucose
时间窗: 8 weeks
Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
FGF-19
时间窗: 8 weeks
Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
次要结局
未报告次要终点
研究者
Marie-Louise Dichman
Principal investigator, MD, Ph.D. student
Hvidovre University Hospital