Prevention of Maternal and Fetal Metabolic Complications With Diet and Nutraceutical Supplementation in Pregnant Women Affected by Gestational Diabetes: a Randomized, Double-blind Placebo Controlled Trial. (PREDIP2)

Prevention of Maternal and Fetal Metabolic Complications With Polyphenols and Omega-3 Fatty Acids Supplementation in Pregnant Women Affected by Gestational Diabetes on Diet Therapy: a Randomized, Double-blind Placebo Controlled Trial.

Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes.

Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.

Study Overview

• Status: Terminated
• Conditions: Oxidative Stress; Gestational Diabetes
• Intervention / Treatment: Dietary supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins; Behavioral: diet; Other: placebo

Detailed Description

Randomized, Double-blind trial Aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo.

All women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. Patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. Blood and urine samples are drawn from all patients at recruitment and at the last study visit.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients between 24 and 28 weeks of gestation with positive result to an Oral Glucose Tolerance Test with 75 gr glucose performed after 24 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl)
• maternal age ≥ 18 years.

Exclusion Criteria:

• multiple pregnancies
• fetal malformation
• maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders)
• abnormal blood glucose values before 24 weeks of gestation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention; patients receiving; diet; Omega-3 fatty acids (EnerZona Omega3Rx®, Enervit, Italia), at a daily dosage of 2.4 gr at breakfast.; Anthocyanins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 108 mg divided into three equal intakes at breakfast, lunch and dinner.; Alpha-cyclodextrins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 15 gr divided into three equal intakes at breakfast, lunch and din-ner	Dietary supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins; administration for 12 weeks; Behavioral: diet; 12 weeks of personalized diet according to the Mediterranean standard diet referrals, the Healthy Eating Plate recommendations of Harvard University School of Public Health, and the reference intake levels of nutrients and energy for the Italian population (LARN) for pregnant women
Placebo Comparator: placebo; patients receiving; diet; placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins)	Behavioral: diet; 12 weeks of personalized diet according to the Mediterranean standard diet referrals, the Healthy Eating Plate recommendations of Harvard University School of Public Health, and the reference intake levels of nutrients and energy for the Italian population (LARN) for pregnant women; Other: placebo; sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins; administration for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
capillary blood glucose level	percentage of patients with median capillary blood glucose values 10 mg/dl below the target (if the fetal abdominal circunference is below 75° percentile according to gestational age: basal level 95 mg/dl, 2-h post prandial level 120 mg/dl; if the fetal abdominal circunference is above 75° percentile according to gestational age: basal level 90 mg/dl, 2-h post prandial level 110 mg/dl;	12 weeks
plasmatic glycated haemoglobin	change in plasmatic glycated haemoglobin	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapy for diabetes	percentage of patients requiring pharmacological treatment for gestational diabetes such as insulin or methformin	12 weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Study Director: Enrico Ferrazzi, Professor, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: PRE.D.I.P.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No