Preventing Recurrent Gestational Diabetes With Metformin

Gestational Diabetes Mellitus Clinical Trial

— PRoDroME  

Official title:

Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02394158
• Other study ID #: 14SM1971
• Secondary ID: 2014-001244-38
• Status: Recruiting
• Phase: Phase 4
• Start date: January 27, 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: Stephen Robinson, FRCP, MD
• Phone: 0203 312 1253
• Email: stephen.robinson[@]imperial.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Description:

Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring.

Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy;

• 8-22 weeks gestation

• Previous pregnancy complicated by gestational diabetes

Exclusion Criteria:

• Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose = 7.0mmol/L and/ or HbA1c = 48mmol/mol); Contraindications to metformin therapy (creatinine = 130µmol/L/ alanine transaminase = 2.0 x upper limit normal/ previous intolerance to metformin)

• Planned continued antenatal care/ delivery at centre not included in trial

• Planned fast for cultural/ religious reasons e.g. Ramadan

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Drug:
• Metformin

• placebo

Locations

Country	Name	City	State
United Kingdom	Imperial College NHS Trust	London
United Kingdom	London North West Healthcare Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust, London North West Healthcare NHS Trust, The Novo Nordisk UK Research Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

De Leo V, Musacchio MC, Piomboni P, Di Sabatino A, Morgante G. The administration of metformin during pregnancy reduces polycystic ovary syndrome related gestational complications. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):63-6. doi: 10.1016/j.ejogrb.2011.03.024. Epub 2011 May 6. — View Citation

Getahun D, Fassett MJ, Jacobsen SJ. Gestational diabetes: risk of recurrence in subsequent pregnancies. Am J Obstet Gynecol. 2010 Nov;203(5):467.e1-6. doi: 10.1016/j.ajog.2010.05.032. Epub 2010 Jul 13. — View Citation

HAPO Study Cooperative Research Group, Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943. — View Citation

Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193. Erratum in: N Engl J Med. 2008 Jul 3;359(1):106. — View Citation

Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin resistance		From 12 weeks gestation until 6 weeks postpartum
Other	Maternal triglyceride concentrations		From 12 weeks gestation until 6 weeks postpartum
Other	Fetal hyperinsulinaemia		Delivery
Primary	Development of Gestational Diabetes at any point during the course of pregnancy		From 12 weeks pregnancy until the onset of labour
Secondary	Maternal gestational weight gain		Difference between weight at 12 weeks gestation and 36 weeks gestation
Secondary	Requirement for insulin therapy		From 12 weeks gestation until 36 weeks gestation
Secondary	Postpartum glucose levels		6 weeks postpartum
Secondary	Levels of maternal physical and psychological health as assessed by questionnaires		From 12 weeks gestation until 6 weeks postpartum
Secondary	Fetal birthweight and birthweight centile		At Birth
Secondary	Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).		At Birth
Secondary	Cost effectiveness of the intervention	Difference in requirement for medical services and unplanned hospital/ General Practitioner attendances between the two arms	From 12 weeks gestation until 6 weeks postpartum