The Effect of Parenterally Administred Semaglutide on Intestinal Iron Absorption in Individuals With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- General objective
研究概览
简要总结
Semaglutide belongs to a group of long-acting glucagon-like peptide 1 receptor agonists (GLP-1). Disorders in iron absorption have been linked to numerous medication, dietary, and nutrient interactions thus far. The study aimed to determine whether there is an effect of concomitant parenteral administration of semaglutide and oral iron preparations on iron absorption in patients with type 2 diabetes (T2DM).
详细描述
Type 2 diabetes mellitus (T2DM) affects over 537 million people worldwide, making it a major chronic and progressive health problem among adults. Novel approaches to managing T2DM have been developed as a result of medical advancements. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are appealing options for the treatment of T2DM, since they efficiently reduce body weight and haemoglobin A1C with a minimal risk of hypoglycaemia.
Semaglutide, a long-acting GLP-1 RA, has a very high structural homology with endogenous GLP-1, high binding affinity to albumin, and resistance to degradation by the intestinal enzyme dipeptidyl peptidase-4. Because of these characteristics and his extended half-life, it can be used once weekly. Similar to all other GLP-1 RAs, semaglutide decreases gastrointestinal motility and slows stomach emptying. Delay in stomach emptying and intestinal motility can interfere with vitamin, mineral, and drug absorption. Iron is one of the essential micronutrients in the human body. On average, 10 - 20 mg of iron is consumed daily through food, but only 1 - 2 mg of iron is absorbed in the duodenum and the first section of the small intestine. It has been shown that drugs which decrease gastrointestinal motility can interfere with iron absorption. However, the relationship between parenteral semaglutide administration and intestine iron absorption has not been the subject of any prior studies. Thus, this study aimed to determine whether there is an effect of parenteral administration of semaglutide on iron absorption in patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM patients
- •ages between 45 and 65
- •with poorly managed T2DM (HbA1c ≥ 7%)
- •who are candidates for treatment intensification and beginning of parenterally administered semaglutide
排除标准
- •hypersensitivity to GLP-1 RAs,
- •adequately controlled with current glucose-lowering medications,
- •already treated with GLP-1 RA,
- •type 1 diabetes mellitus or any other form of diabetes,
- •hemochromatosis,
- •iron deficiency anaemia,
- •sideropaenia,
- •severe chronic illnesses,
- •malignant neoplasms of any site,
- •chronic infectious diseases,
- •chronic rheumatic inflammatory diseases,
- •malabsorption syndrome,
- •inflammatory bowel disease,
- •history of gastrointestinal tract reduction surgery,
- •medications that interfere with absorption,
- •perimenopausal women
研究组 & 干预措施
T2DM subjects before and at week 10 of semaglutide therapy
Patient demographic and clinical data was collected and entered into a database made specifically for the study. The patients were examined, and their vital signs and body measures were recorded. Before the introduction of semaglutide therapy all participants completed an oral absorption iron test (OIAT). As described in previous studies, OIAT was conducted in an outpatient setting. Following the initial OIAT therapy with semaglutide was started. Each subject received parenterally administered one-weekly semaglutide. To enhance glycaemic control, the therapy was up-titrated every four weeks. Initially, the dose was set at 0.25 mg once a week, four weeks later, it was raised to 0.5 mg once weekly, and four weeks after that, it was increased to 1 mg once weekly. After reaching the maximum maintenance dosage of 1 mg for two weeks, each T2DM patient completed a follow-up OIAT at week 10 of the study. Data from the first and subsequent OIATs were analysed statistically.
干预措施: semaglutide (Drug)
结局指标
主要结局
General objective
时间窗: 10 weeks
Number of T2DM participant that will have reduction in intestinal iron absorption after the semaglutide administration
次要结局
- Specific objectives(10 weeks)
研究者
Petra Meliš
Principal Investigator
University Hospital Dubrava