Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated

NCT03763669 | Completed

• 1 other identifier: UMessina
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to verify the beneficial effects on insulin resistance and fetal sonographic parameters of a diet supplementation of myoinositol taken during the third trimester by pregnant women affected by gestational diabetes. Participants should be randomly allocated to take either myoinositol or placebo twice/day for 8 weeks. The effect of myoinositol will be checked in blood samples (insulinemia and Homeostasis Model Assessment - Insulin Resistance "HOMA-IR") and in fetal sonographic parameters after 4 and 8 weeks from the beginning of the nutritional supplementation.

Conditions

Gestational Diabetes

Keywords

Insulin resistance; Fetal sonographic parameter; Myoinositol

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  Change from baseline to 8 weeks of HOMA-IR calculated as glycemia (mmol/L) x insulinemia (mUI/L) / 22.5

  Start point, and 8 weeks after

Secondary Outcomes (1)

• Fetal sonographic parameters

  Start point, 4 and 8 weeks after

Study Arms (2)

Intervention

EXPERIMENTAL

Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation

Dietary Supplement: Myoinositol

Control

PLACEBO COMPARATOR

Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day)

Dietary Supplement: Placebo (for myoinositol)

Interventions

Myoinositol DIETARY_SUPPLEMENT

myo-inositol (2 g. twice a day)

Also known as: Folic acid

Intervention

Placebo (for myoinositol) DIETARY_SUPPLEMENT

(twice a day)

Also known as: Folic acid

Control

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy affected by gestational diabetes

You may not qualify if:

• Multiple pregnancy and known or suspected fetal malformations

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

Department of Obstetrics & Gynecology - Policlinico "G. Martino"

Messina, 98125, Italy

Location

Related Publications (3)

• Santamaria A, Alibrandi A, Di Benedetto A, Pintaudi B, Corrado F, Facchinetti F, D'Anna R. Clinical and metabolic outcomes in pregnant women at risk for gestational diabetes mellitus supplemented with myo-inositol: a secondary analysis from 3 RCTs. Am J Obstet Gynecol. 2018 Sep;219(3):300.e1-300.e6. doi: 10.1016/j.ajog.2018.05.018. Epub 2018 May 30.

  PMID: 29859136 BACKGROUND

• Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.

  PMID: 21414183 BACKGROUND

• D'Anna R, Corrado F, Loddo S, Gullo G, Giunta L, Di Benedetto A. Myoinositol plus alpha-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study. Sci Rep. 2021 Apr 23;11(1):8866. doi: 10.1038/s41598-021-88329-x.

  PMID: 33893377 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Inositol; Folic 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; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Placebo administered
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myoinositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 4, 2018
• Study Start: November 14, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

IT (1)