Comparative Effects of Metformin and Insulin on Stereological Studies and Immunohistochemistry of Placenta
Comparative Studies of Metformin and Insulin on Stereological Studies and Immunohistochemistry of Placenta
1 other identifier
interventional
156
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2019
CompletedFirst Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedJune 1, 2021
May 1, 2021
1.1 years
May 17, 2021
May 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean morphometric diffusion capacity for oxygen (MMDC) in placental tissues
With detailed stereological assessment MMDC can be calculated for the placenta to visualize which group placenta allows better diffusion of oxygen
15 months
Secondary Outcomes (1)
Percentage of immuno-antigens present in placental tissue
15 months
Study Arms (4)
Normal healthy controls
NO INTERVENTIONfemales in second trimester with normal glucose levels
Diet controlled
NO INTERVENTIONfemales in second trimester with blood sugar levels below 129mg/dl
Metformin
EXPERIMENTALfemales in second trimester with blood sugar levels above 130mg/dl treated with Metformin
Insulin
EXPERIMENTALfemales in second trimester with blood sugar levels above 130mg/dl being treated with Insulin
Interventions
Eligibility Criteria
You may qualify if:
- For this study placentae were collected from:
- 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.
You may not qualify if:
- Placentae were not collected from:
- GDM Patients with ages less than 18 or more than 40 years
- 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).
- GDM Patients who delivered pre-termed (\< 37 weeks of gestation) or post termed (\>42 weeks of gestation)
- GDM patients with twin pregnancy.
- GDM Patients if not preserved in the formalin properly within 30-40 minutes of delivery.
- GDM females who were given combined (Metformin and insulin) therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinnah Post Graduate Medical Centre
Karachi, Sindh, 75510, Pakistan
Related Publications (1)
Liang HL, Ma SJ, Xiao YN, Tan HZ. Comparative efficacy and safety of oral antidiabetic drugs and insulin in treating gestational diabetes mellitus: An updated PRISMA-compliant network meta-analysis. Medicine (Baltimore). 2017 Sep;96(38):e7939. doi: 10.1097/MD.0000000000007939.
PMID: 28930827BACKGROUND
Related Links
- Belkacemi, L., Kjos, S., Nelson, D. M., \& Desai, M. (2013). Reduced apoptosis in term placentas from gestational diabetic pregnancies. Journal of Developmental Origins of Health and Disease, 4 (3), 256-265.
- Casson, I. F., Clarke, C, A., Howard, C.V., McKendrick, O., Pennycook, S., Pharoah, P.O.D. (1997). Outcomes of pregnancy in insulin dependent diabetic women: results of a five-year population cohort study, British Medical Journal, 315, 275.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
KAUSER AAMIR, Ph.D
BMSI, JPMC,KARACHI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2021
First Posted
June 1, 2021
Study Start
January 1, 2018
Primary Completion
February 10, 2019
Study Completion
August 7, 2019
Last Updated
June 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share