EUCTR2022-000157-87-DK进行中（未招募）1 期
HypoBar I: Delaying intestinal glucose absorption to ameliorate post-bariatric hypoglycaemia. A randomized cross-over clinical trial. - HypoBarI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •At enrolment, participants must:
- •Be adults (above 18 years old);
- •Have undergone bariatric surgery more than 18 months prior to inclusion;
- •Self-reported weight stability (less than 5% variation over the 6 months);
- •Present at least one 5-minutes or longer event of interstitial fluid glucose <3.0 mmol/L, one 5-minutes symptomatic event of IFG<3.9mmol/L (allowing a time gap between symptoms reported and low glucose values of ±30 minutes) at least 4.0% of IFG <3.9mmol/L during a min 10 days CGM monitoring screening period, excluding first 24 hours of monitoring (prone to error due to local inflammatory reaction);
- •Have a negative pregnancy test, if applicable;
- •Commit to safe contraception during the trial and over the following 5 months, namely intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or double barrier methods (a condom combined with a diaphragm).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All patients presenting one of the following at enrolment will be excluded:
- •Altered baseline analytical profile, namely an early morning 12h-fasting blood test with hemogram, liver and kidney functions tests, albumin, total proteins, plasma glucose, TSH, insulin, C-peptide, and beta-hCG and thus pointing towards other potential causes for hypoglycaemia and/or prone to unsafety to pursue the trial*;
- •Inability or unwillingness to perform meal test (e.g. unable to have the meal over 20 minutes);
- •Pharmacotherapy that affects glucose metabolism:
- •Glucocorticoid treatment within 6 weeks of inclusion;
- •Somatostatin analogue treatment within 4 months of inclusion;
- •GLP-1 receptor analogue treatment within 6 half-lives of inclusion;
- •SGLT2 inhibitor treatment within 2 weeks of inclusion.
- •HbA1c >47.5 mmol/mol [>6.5%;]
- •Antithyroid treatment within 3 months of inclusion or poorly managed thyroid disease (TSH outside reference range);
- •Pregnancy (positive pregnancy test), aspiring to get pregnant over the following 5 months or lactation;
- •Renal insufficiency (eGFR <60 ml/min/1.73m2);
- •Elevation of liver enzymes (>3 x elevation of upper normal limit of alanine amino transferase and/or alkaline phosphatases);
- •Poorly controlled psychiatric disease or mental retardation;
- •Alcohol or other substance abuse;
- •Significant anaemia (Hb <6.0 mmol/L);
- •Recent history of major adverse cardiovascular events (MACE), such as hospitalizations for heart failure, nonfatal stroke, or nonfatal myocardial infarction within the previous 12 months;
- •Any other condition that in the opinion of the investigator may compromise outcome;
- •Sustained intolerance to study drugs.
研究者
相似试验
已完成
不适用
Closed Loop In Pregnancy: evaluation of the gut absorption rate of glucose during an evening meal and breakfast in women with type 1 diabetes throughout pregnancyISRCTN62568875Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)12
已完成
不适用
The rate of glucose uptake over the blood-brain barrier in humans in vivo, measured by 13C magnetic resonance spectroscopy10018424DiabetesDiabetes MellitusNL-OMON36330niversitair Medisch Centrum Sint Radboud16
已完成
不适用
Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR enterography in patients not taking metformitype 2 diabetes mellitusJPRN-UMIN000045137Kobe university5
尚未招募
不适用
Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR enterography in patients taking imeglimitype 2 diabetes mellitusJPRN-UMIN000045345Kobe university5
尚未招募
Unknown
Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimitype 2 diabetes mellitusJPRN-UMIN000049426Kobe University10