Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

NCT ID: NCT02275845

Last Updated: 2015-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-09-30

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

Detailed Description

Rationale: GDM is a frequent pregnancy complication1 and associated with complications for mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the last years several studies documented the use of oral blood glucose lowering medication in GDM. Metformin is an accepted alternative for insulin, with comparable glycemic control and neonatal outcomes.4 In studies with women with polycystic ovarian syndrome (PCOS) who received Metformin during pregnancy, the incidence of GDM is less compared to pregnant women with PCOS without Metformin. These studies were however small and there was no adequate control group.5 Our aim is to study the effect of Metformin on the incidence of GDM in women with a high risk for GDM.

Objective: the primary objective is to compare metformin versus no intervention for incidence of GDM in women with a high risk for GDM. The main secondary objective is pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.

Study design: 2 years open label randomized controlled trial, comparing metformin versus control group.

Study population: pregnant women with a high risk of GDM between 18 and 40 years old in the first trimester of pregnancy.

Intervention: the first group receives Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. The second group receives no intervention. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.

Main study parameters/endpoints: the main study parameter is the difference in incidence of GDM between the two groups.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the subjects will visit our centre for the first time between 12 and 14 weeks of pregnancy, then blood samples will be collected. Further on they will visit our centre at 24 weeks to perform an oral glucose tolerance test (OGTT). Women with GDM in history will perform an OGTT at 16 weeks for the first time. If the OGTT is borderline normal, it will repeated every 4 weeks. This is according to current Dutch guidelines3, without any extra discomfort for study participants. The subjects will visit their own gynaecologist or obstretican for their regular pregnancy controls. Metformin is not officially registered for use in pregnancy. Long term effects for the unborn child are not known. However, previous studies did not found neonatal and pregnancy related complications.

Conditions

Gestational Diabetes Mellitus

Keywords

metformin; prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

intervention

Metformin 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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)

control diet

Intervention Type: OTHER

2000 calories/day diet, with an adequate distribution of carbohydrates during the day

control diet

a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.

Group Type: ACTIVE_COMPARATOR

control diet

Intervention Type: OTHER

2000 calories/day diet, with an adequate distribution of carbohydrates during the day

Interventions

Metformin

Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)

Intervention Type: DRUG

control diet

2000 calories/day diet, with an adequate distribution of carbohydrates during the day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wetenschapsbureau

dr. J. van der Linden

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joke van der Linden, dr.

Role: PRINCIPAL_INVESTIGATOR

Maasstad Hospital

Locations

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Joke van der Linden, dr.

Role: CONTACT

Phone: +31 10 291 2382

Email: wetenschapsbureau@maasstadziekenhuis.nl

Facility Contacts

Huguette Brink, Drs

Role: primary

Wetenschapsbureau

Role: backup

Other Identifiers

2014-000446-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL48005.101.15

Identifier Type: -

Identifier Source: org_study_id