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

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

Diabetes mellitus is a group of metabolic disorder characterized by high blood glucose level mainly due to defect in insulin secretion or resistance.

Placenta is a vital organ as it provides nutrition to the fetus.

It had four arms (groups): Normal healthy controls (no intervention), Diet controlled (no intervention), Metformin (experimental) and Insulin (experimental).

Females in second trimester with normal glucose levels.

The registry classes the interventions as drug.

More on the Plan

Diabetes mellitus is a group of metabolic disorder with relative or absolute deficiency of insulin.

Placenta is an important feto-maternal organ which is responsible for nutrition of the fetus.

It also provides the retrospective information regarding infant's prenatal development.

Structurally, human placenta is a complex vascular organ that allows exchange of nutrients and chemicals between fetal and maternal blood.

Who Took Part

Enrollment: 156 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients who were diagnosed as GDM during second trimester screening for FBS and RBS, confirmed further by OGCT and OGTT. GDM patients who signed the written informed consent. GDM patients who were in ages between 18 years and 40 years and had no other comorbid such hypertension, CVD etc. Full term GDM patients with singleton pregnancy (37 weeks and above). GDM patients whose placenta were preserved within 30-40 minutes of delivery.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: GDM Patients with ages less than 18 or more than 40 years; GDM Patients who delivered pre-termed (\< 37 weeks of gestation) or post termed (\>42 weeks of gestation); GDM patients with twin pregnancy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2018-01-01 with completion listed for 2019-02-10.

It ran at 1 site in Pakistan.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Mean morphometric diffusion capacity for oxygen (MMDC) in placental tissues (time frame: 15 months).

It also tracked 1 secondary outcome, for example Percentage of immuno-antigens present in placental tissue.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 156 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.