Clinical trial NCT05393843: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gestational Diabetes
Oxidative Stress
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: capillary blood glucose level
timeFrame: 12 weeks
measure: plasmatic glycated haemoglobin
timeFrame: 12 weeks
Secondary outcomes:
measure: therapy for diabetes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Enrico Ferrazzi, Professor
role: STUDY_DIRECTOR
References: