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

NCT04907708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-06-01

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Arising in Pregnancy, Insulin-Requiring
  • Diabetes Mellitus in Pregnancy

Interventions

DRUG

Metformin

Euglycemic agent

DRUG

Insulin

Hypoglycemic agent

Sponsors & Collaborators

  • University of Karachi

    lead OTHER

Principal Investigators

  • KAUSER AAMIR, Ph.D · BMSI, JPMC,KARACHI

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04907708 on ClinicalTrials.gov