Prevention of Gestational Diabetes; a Study Targeting Early Pregnancy Intervention to Women at Risk

Phase 1

• Conditions: Gestational diabetes mellitus; MedDRA version: 21.1 Level: LLT Classification code 10018210 Term: Gestational diabetes mellitus System Organ Class: 100000004868; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-000003-16-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-05
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Female, over 16 years
BMI =30kg/m2
High risk of GDM as identified by the risk assessment at screening
Singleton pregnancy
Gestation 21-14+6 weeks’ at the time of screening consent
Willing and able to give written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women identified as being low risk of GDM
Pre-existing diabetes
HbA1c =6.5mmol/l at screening in early pregnancy
Hypertension requiring treatment pre-pregnancy/in pregnancy
Thyroid disease
Coeliac disease
Systemic Lupus Erythematosus
Antiphospholipid syndrome (APS)
Thalassaemia
Current psychosis
Taking metformin
Taking medications that affect insulin sensitivity
Past bariatric surgery
Sickle Cell
Multiple pregnancy
Insufficient understanding of the trial
Participation in another IMP trial at the time of screening consent
Contraindications to Metformin:
• Hypersensitivity to metformin hydrochloride or to any of the excipients.
• Diabetic ketoacidosis, diabetic pre-coma
• Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)
• Acute conditions with the potential to alter renal function such as:
- dehydration
- severe infection
- shock
- intravascular administration of iodinated contrast agents
• Acute or chronic disease which may cause tissue hypoxia such as:
- cardiac or respiratory failure
- recent myocardial infarction
- shock
• Hepatic insufficiency, acute alcohol intoxication, alcoholism
• Lactation
• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
• Severe renal failure (GFR <30 mL/min)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess in obese pregnant women at high risk of GDM the efficacy of a) dietary advice, b) metformin treatment plus dietary advice to improve maternal glycaemic control when compared with c) standard care.;<br> Secondary Objective: 1) To assess feasibility of risk assessment for GDM using the new prediction tool in obese women.<br> 2) To determine the impact of each intervention on a targeted maternal metabolome (Nuclear Magnetic Resonance, NMR).<br> 3) To examine the effect of each intervention on dietary intake.<br> ;Primary end point(s): A reduction in mean glucose/24hr of 0.5mmol/l after 8-week treatment, as assessed using continuous glucose monitoring.;Timepoint(s) of evaluation of this end point: Primary outcome will be evaluated at 22-25 weeks gestation.