drugset / Trial / NCT04907708

Comparative Effects of Metformin and Insulin on Stereological Studies and Immunohistochemistry of Placenta

NCT04907708

Completed 156 enrolled University of Karachi
RandomizedParallel-groupOpen-labelOther

Summary

Diabetes mellitus is a group of metabolic disorder characterized by high blood glucose level mainly due to defect in insulin secretion or resistance. In pregnancy, insulin resistance increases as the pregnancy advances, due to the placental hormones predisposing the female to gestational diabetes mellitus (GDM). Placenta is a vital organ as it provides nutrition to the fetus. It shows morphological changes in patients with GDM leading to feto-maternal complications. Insulin, a traditional treatment given for GDM is also known to cause intra uterine deaths, stillbirths and hypoglycemia in mothers and newborns. Insulin being anabolic hormone makes placenta larger in size and causes hypoxic changes with vascular insufficiency, infarctions and hemorrhages. In contrast to this, oral insulin sensitizing drug Metformin, is euglycemic in nature. It has been proven now that Metformin is a vasculo-protective agent, with better patient compliance and beneficial micro-vascular effects in type 2 diabetics. This study was designed to clearly visualize in detail if there are any unrevealed beneficial vascular effects of Metformin on placental tissues and also to compare these effects with Insulin and diet restriction therapy, by doing placental light microscopy, morphometric studies and immunohistochemistry.

Timeline

Start
2018-01-01
Primary completion
2019-02-10
Completion
2019-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Other
Subject Metformin Small molecule Oral

Indications