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

Prevention of Gestational Diabetes in Obese Pregnant Women; a Proof of Principle Study Targeting Early Pregnancy Intervention to Women at Risk - UPBEAT-TIF

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000003-16-GB

Enrollment

Registered

2018-09-05

Start date

2018-11-06

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus MedDRA version: 21.1 Level: LLT Classification code 10018210 Term: Gestational diabetes mellitus System Organ Class: 100000004868

Interventions

Product Name: Metformin 500mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: Metformin CAS Number: 657-24-9 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: 1) To assess feasibility of risk assessment for GDM using the new prediction tool in obese women. 2) To determine the impact of each intervention on a targeted maternal metabolome (Nuclear Magnetic Resonance, NMR). 3) To examine the effect of each intervention on dietary intake. ;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.	—

Measure

Time frame

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.; Secondary Objective: 1) To assess feasibility of risk assessment for GDM using the new prediction tool in obese women. 2) To determine the impact of each intervention on a targeted maternal metabolome (Nuclear Magnetic Resonance, NMR). 3) To examine the effect of each intervention on dietary intake. ;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.

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Secondary

Measure	Time frame
Secondary end point(s): a) Other glycaemic parameters; mean daytime glucose 0.700-23.00h, mean nocturnal glucose 23.00-0.700h, percentage time in tight glucose control target 3.5- 6.7mmol/L, percentage time in NICE recommended glucose control target 3.5-7.8mmol/L, AUC <6.7mmol/L, AUC <7.8mmol/L, glucose variability measures (glucose SD, glucose CV standard deviation, correlation of coefficient), High Blood glucose index (HBGI), Low Blood glucose index after 8-week treatment and at 32-36 weeks gestation; GDM diagnosis at 24-28 weeks' (IADPSG and NICE criteria). b) metabolome at 14-17 weeks and 24-28 weeks gestation. c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation. ; Timepoint(s) of evaluation of this end point: a) Other glycaemic parameters; 22-25 weeks gestation and at 32-36 weeks gestation; GDM diagnosis at 24-28 weeks' gestation. b) metabolome at 14-17 weeks and 24-28 weeks gestation c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation	—

Measure

Time frame

Secondary end point(s): a) Other glycaemic parameters; mean daytime glucose 0.700-23.00h, mean nocturnal glucose 23.00-0.700h, percentage time in tight glucose control target 3.5- 6.7mmol/L, percentage time in NICE recommended glucose control target 3.5-7.8mmol/L, AUC <6.7mmol/L, AUC <7.8mmol/L, glucose variability measures (glucose SD, glucose CV standard deviation, correlation of coefficient), High Blood glucose index (HBGI), Low Blood glucose index after 8-week treatment and at 32-36 weeks gestation; GDM diagnosis at 24-28 weeks' (IADPSG and NICE criteria). b) metabolome at 14-17 weeks and 24-28 weeks gestation. c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation. ; Timepoint(s) of evaluation of this end point: a) Other glycaemic parameters; 22-25 weeks gestation and at 32-36 weeks gestation; GDM diagnosis at 24-28 weeks' gestation. b) metabolome at 14-17 weeks and 24-28 weeks gestation c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation

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Countries

United Kingdom

Contacts

Public ContactDr Sara White

King's College London

sara.white@kcl.ac.uk+4402071883642

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026