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

• Status: Completed
• Trial end date: 2019-08-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Karachi
• Treatments: Metformin

Criteria

Inclusion Criteria:

For this study placentae were collected from:

1. Patients who were diagnosed as GDM during second trimester screening for FBS and RBS, confirmed further by OGCT and OGTT.

2. GDM patients who signed the written informed consent.

3. GDM patients who were in ages between 18 years and 40 years and had no other comorbid such hypertension, CVD etc

4. Full term GDM patients with singleton pregnancy (37 weeks and above)

5. GDM patients whose placenta were preserved within 30-40 minutes of delivery.

Exclusion Criteria:

Placentae were not collected from:

1. GDM Patients with ages less than 18 or more than 40 years

2. GDM females with some co-morbid and complications (e.g. hypertension, CVD, diabetes type 1 or diabetes type 2 before gestation, abnormal Urea Creatinine Electrolyte (UCE) and Liver function test (LFTs).

3. GDM Patients who delivered pre-termed (< 37 weeks of gestation) or post termed (>42 weeks of gestation)

4. GDM patients with twin pregnancy.

5. GDM Patients if not preserved in the formalin properly within 30-40 minutes of delivery.

6. GDM females who were given combined (Metformin and insulin) therapy.