甲福明与胰岛素在怀孕中的血糖控制 (MevIP):一个随机临床试验协议
Carolina Freitas Alves Amaral-Moreira1, Daiane Sofia Morais Paulino1, Belmiro G Pereira1
1Department of Obstertrics & Gynecology, School of Medical Science, Universidade Estadual de Campinas, Campinas, Brazil.
Trials
|February 8, 2025
概括
在巴西,甲福明可能是胰岛素治疗妊娠糖尿病 (GDM) 的有效替代品. 这项研究比较了用于GDM管理的甲福明和胰岛素,重点关注血糖控制和孕产妇/新生儿结局.
科学领域:
- 产科和妇科 产科和妇科
- 内分泌学 在内分泌学.
- 公共卫生 公共卫生
背景情况:
- 孕期糖尿病 (GDM) 影响巴西5-18%的怀孕,对孕妇和新生儿的健康构成重大风险.
- 胰岛素是标准的第一线治疗,但低收入和中等收入国家存在对成本和可获得性的担忧.
- 甲胺作为一种安全且可能更有效的替代品显示出前景,研究表明其好处包括减少妊娠期体重增加.
研究的目的:
- 为了比较甲福尔与胰岛素在巴西人口中管理GDM的疗效和安全性.
- 评估使用甲福明或胰岛素治疗的孕妇GDM的血糖控制,妊娠期体重增加和孕妇-新生儿结局.
主要方法:
- 一项开放的随机对照试验 (RCT) 涉及92名患有GDM或II型糖尿病的孕妇.
- 参与者被随机分配,接受甲胺 (干预) 或胰岛素 (标准护理).
- 主要结局:血糖控制. 其次性结局:妊娠期间体重增加,高血压综合征,巨和新生儿低血糖症. 通过产后的随访.
主要成果:
- 这项研究正在进行中,结果尚未公布.
- 该试验已注册 (ID RBR-3j3cktx),并遵循治疗意图分析.
结论:
- 预计MevIP研究将证明甲双是巴西GDM治疗中胰岛素的可行和适当替代品.
- 结果可能会影响GDM管理准则,特别是在资源有限的环境中,通过提供一个潜在的更容易获得的治疗选择.
相关概念视频
Oral Hypoglycemic Agents: Biguanides and Glitazones
160
Biguanides, particularly metformin (Glucophage), are insulin sensitizers that enhance glucose uptake, thereby reducing insulin resistance. Unlike sulfonylureas, metformin doesn't prompt insulin secretion, which helps to curb hypoglycemia risk. Metformin is beneficial in treating conditions like polycystic ovary syndrome due to its insulin-resistance reduction capability. The drug's primary action involves curtailing hepatic gluconeogenesis, a significant contributor to high blood...
160
Diabetes Mellitus: Type 2 and Gestational
2.1K
Type 2 diabetes, characterized by insulin resistance, arises when the insulin receptors on cells lose responsiveness to insulin, diminishing the cell's capacity to take up glucose, resulting in elevated blood glucose levels. To receive a diagnosis of Type 2 diabetes, a series of blood glucose tests are necessary to assess whether the blood glucose falls within normal parameters. If the result is out of the normal range, a patient may be diagnosed as prediabetic or diabetic, depending on the...
2.1K
Pathophysiology of Diabetes
848
Diabetes mellitus is a chronic metabolic disorder characterized by hyperglycemia. The four categories of diabetes are type 1 diabetes, type 2 diabetes, other specific types of diabetes, and gestational diabetes.
Type 1 diabetes is characterized by autoimmune-mediated destruction of pancreatic β cells, with environmental factors potentially triggering this process in genetically susceptible individuals. Despite many not having a family history, certain genes increase susceptibility,...
Type 1 diabetes is characterized by autoimmune-mediated destruction of pancreatic β cells, with environmental factors potentially triggering this process in genetically susceptible individuals. Despite many not having a family history, certain genes increase susceptibility,...
848
Oral Hypoglycemic Agents: Glinides
131
Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively...
131
Dipeptidyl Peptidase 4 Inhibitors
164
Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a...
164
Diabetes: Management and Pharmacotherapy
232
The therapy for diabetes aims to alleviate hyperglycemia-related symptoms, prevent acute metabolic decompensation, and reduce chronic end-organ complications. Glycemic control is evaluated through short-term (self-monitoring, continuous glucose monitoring) and long-term (A1c, fructosamine) metrics, enabling near real-time tracking of blood glucose levels and reflecting glycemic control over specific time frames.
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
232


