Gestational Treatment With Ursodeoxycholic Acid Compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus Diagnosed at 24-28 Weeks' Gestation

NCT06127355 | Completed Phase 3

• 1 other identifier: IMIB-GU-2019-02
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will compare the influence of treatment with ursodeoxycholic acid (UDCA) compared to placebo on glycaemic control (primary outcome) in women with GDM after a positive diagnosis at 24-28 weeks of gestation. The investigators will evaluate maternal and fetal lipid and glucose metabolism. Neonatal health outcomes will also be studied, including the rate of LGA. UDCA is used to treat the commonest liver disease of pregnancy, intrahepatic cholestasis of pregnancy (ICP), and has good safety data to support its use in pregnancy 52-57 ., it means, no studies reported any increase in adverse outcomes associated with UDCA treatment. It is noteworthy that in the largest study 52, 8 serious adverse events were reported, 6 of which were in the placebo group, and none were considered to be related to the trial intervention. There were 72 adverse events: 31 in the ursodeoxycholic acid group and 41 in the placebo group. The same number of patients in each group (n=10) reported adverse events related to gastrointestinal disorders.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Maternal fasting glucose concentration at 36 weeks

  aiming to maintain all capillary glucose levels between 3.9-7.8mmol/l (70 - 140 mg/dL). The specific pre- and post-meal self-monitored blood glucose (SMBG) targets are ≤5.3mmol/L before breakfast (95 mg/dL), ≤7.8mmol/L 1-hr post meal (140 mg/dL) and ≤6.7mmol/L (120 mg/dL) 2-hr post meal.

  Up to 36 weeks

Secondary Outcomes (4)

• Proportion of women requiring insulin treatment

  Up to 36 weeks

• Proportion of delivery type

  Up to 40 weeks

• Gestational age at delivery, frequency of preterm delivery

  Up to 40 weeks

• Infant birth weight

  Up to 40 weeks

Study Arms (2)

Ursodeoxycholic Acid

EXPERIMENTAL

500 mg of ursodeoxycholic acid (UDCA)

Drug: 500 mg of ursodeoxycholic acid (UDCA)

Control

PLACEBO COMPARATOR

500 mg of Placebo

Other: 500 mg of Placebo

Interventions

500 mg of ursodeoxycholic acid (UDCA) DRUG

Administration of 500 mg of ursodeoxycholic acid (UDCA) /day

Ursodeoxycholic Acid

500 mg of Placebo OTHER

Administration of 500 mg of placebo /day

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gestational treatment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with GDM diagnosed at 24-28 weeks' gestation in accordance with Spanish guidelines in accordance with NDDG criteria, i.e. two or more glucose concentrations (fasting: ≥ 5.8 mmol/L (105 mg/dL), 1 h: ≥10.6 mmol/L, (190 mg/dL) 2 h: ≥9.2 mmol/L (165 mg/dL), 3 h: ≥ 8.1 mmol/L (145 mg/dL)) after a standard 100g OGTT, two fasting blood glucose levels ≥ 126 mg/dl, on different days, or at random ≥ 200 mg/dL or a plasma glucose value greater than 200 mg/dL after OSullivan test
• Planned antenatal care at the same centre (i.e. not planning to move before delivery).
• Singleton pregnancy.
• Informed and written consent.

You may not qualify if:

• Age \<18 years;
• Multiple pregnancy in current pregnancy;
• Unconscious or very ill;
• Serious mental illness;
• Learning difficulties;
• Not fluent in local language and absence of interpreter.
• Severe congenital anomaly on ultrasound
• Previous diagnosis of diabetes outside of pregnancy
• Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (\<1 year)
• Significant co-morbidity in the current pregnancy, nephropathy (estimated GF\<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results
• Participating in another intervention study that will influence the outcome of this trial (to be advised by CI or PI).
• Known allergy/hypersensitivity/intolerance to the active substance or excipients.
• Hypersensitivity to Ursodexosolic acid or to the following excipients: Magnesium stearate, cellulose powder, colloidal silica and sodium carboxymethyl starch, gelatin, titanium dioxide, quinoline yellow, orange yellow S, indigotine.
• Patients with a non-functioning gallbladder, in patients with calcified cholesterol stones, radio-opaque stones, radiolucent gallbladder stones.
• Gastric or duodenal ulcer.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 3, 2021
• Primary Completion: February 9, 2022
• Study Completion: May 10, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)