Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus
Medico-GDM
Metformin vs Control to Prevent Gestational Diabetes Mellitus (GDM) in Women With a High Risk for GDM, an Open Label Randomized Controlled Trial, The Medico-GDM Trial
2 other identifiers
interventional
400
1 country
1
Brief Summary
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2014
Typical duration for phase_3
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 28, 2015
December 1, 2015
2 years
October 23, 2014
December 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of gestational diabetes mellitus in both groups
from 14 weeks pregnancy untill delivery
Secondary Outcomes (2)
Maternal outcomes
from 14 weeks pregnancy untill delivery
Neonatal outcomes
from 14 weeks pregnancy untill delivery
Study Arms (2)
intervention
EXPERIMENTALMetformin twice daily 500 mg for the first week, after that twice daily 1000 mg. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
control diet
ACTIVE COMPARATORa diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
Interventions
Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)
2000 calories/day diet, with an adequate distribution of carbohydrates during the day
Eligibility Criteria
You may qualify if:
- a subject must meet all of the following criteria:
- high risk (according to ductch national criteria) for gestational diabetes
- aged between 18 and 40 years
- gestational age between 8 and 12 weeks
- and able to communicate and read in Dutch.
You may not qualify if:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- no singleton pregnancy judged by ultrasonography
- diagnosis of diabetes mellitus before the current pregnancy-
- high fasting glucose at first trimester (\> 5.3 mmol/l)
- cardiac insufficiency-\\
- renal insufficiency (MDRD \< 60)
- liver disease
- use of medication other than Paracetamol or vitamins and incompetent women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maasstad Ziekenhuis
Rotterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joke van der Linden, dr.
Maasstad Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr. J. van der Linden
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 27, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
December 28, 2015
Record last verified: 2015-12