Does Metformin reduce the future risk of overweight babies?

Phase 1

• Conditions: Obesity in pregnancy; MedDRA version: 15.0 Level: PT Classification code 10036556 Term: Pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 15.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2009-017134-47-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Caucasian obese (BMI = 30 kg/m2) pregnant women between = 12-0 and = 16+0 weeks gestation
Women age =16 years
Signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Non Caucasian women
•Women with a BMI = 29 kg/m2
•Gestation > than 16 weeks
•Women with pre-existing diabetes
•Women with gestational diabetes in a previous pregnancy
•Women with systemic disease requiring medication.
•Gestational diabetes in index pregnancy (diagnosed with 75g OGTT tested (WHO criteria prior to randomisation)
•A known pregnancy complications in this or a previous pregnancy likely to impact of birthweight or gestation at delivery
•A known hypersensitivity to metformin hydrochloride or to any of the excipient.
•Known abnormalities of the liver (tested prior to randomisation)
•Renal failure or renal dysfunction
•Acute conditions with the potential to alter renal function such as:
odehydration,
osevere infection,
oshock,
ointravascular administration of iodinated contrast agents
oAcute or chronic diseases which may cause tissue hypoxia such as:
ocardiac or respiratory failure,
orecent myocardial infarction,
oshock
ohepatic insufficiency, acute alcohol intoxication, alcoholism,
•Lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies. ;Secondary Objective: We will use metformin administration as a tool to explore the mechanism by which obesity causes adverse pregnancy outcomes, with a particular focus on insulin resistance (IR). ;<br> Primary end point(s): 1.What is the efficacy of metformin (up to 2500mg daily), given to obese pregnant women from 12 - 16 weeks gestation until delivery in reducing birthweight centile of the baby?<br> 2.What is the pattern of association between insulin resistance and adverse pregnancy outcome in obese pregnant women?<br>