Inositol Stereoisomers to Treat Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02097069
• Other study ID #: VITA01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 27, 2014
• Last updated: March 23, 2014
• Start date: April 2014

Study information

• Verified date: March 2014
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.

The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).

Folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.

The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.

Description:

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance that begins or is first recognized during pregnancy (1). It is characterized by an increase of physiological insulin resistance and it is associated with an increased risk of perinatal and maternal morbidity (2,3).

Inositol is a six-carbon polyol, normally present in a variety of foods, which has been classified as an insulin sensitizing agent. It exists as nine different isomers including myo-inositol (MI) and D-chiro-inositol (DCI) that are the most represented in human body. Myo-inositol and D-chiro-inositol glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels (4-5).

Recently has been demonstrated that Myo-inositol supplementation improves insulin resistance in patients with GDM (6), whereas there aren't data about the use of D-chiro-inositol or Myo-inositol plus D-chiro-inositol in women affected by GDM.

In this proposed study, the investigators aim to compare the effect of different inositol stereoisomers supplementation (Myo-inositol, D-chiro-inositol or Myo-inositol plus D-chiro-inositol ) in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. All the available inositol formulations also contain folic acid (200 mcg).

The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).

Dietary control, folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.

The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Gestational Diabetes diagnosed within 24-28 weeks gestation

• Caucasian pregnant women

Exclusion Criteria:

• Pre-pregnancy diabetes

• Non-singleton pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Dietary Supplement:
• Folic acid
Folic acid 400 mcg/day
• Myo-inositol
myo-inositol 2000 mg twice a day
• D-Chiro-inositol
D-chiro inositol 250 mg twice a day
• Myo-inositol plus D-chiro inositol
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day

Locations

Country	Name	City	State
Italy	Hospital "SS Annunziata"	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Casey BM, Lucas MJ, Mcintire DD, Leveno KJ. Pregnancy outcomes in women with gestational diabetes compared with the general obstetric population. Obstet Gynecol. 1997 Dec;90(6):869-73. — View Citation

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. — View Citation

Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10. Review. — View Citation

Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. Review. — View Citation

Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. — View Citation

Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)		56 days- 8 weeks	No
Secondary	hypertensive disorders		56 days- 8 weeks	No
Secondary	macrosomia		at delivery	No
Secondary	cesarean section		at delivery	No
Secondary	neonatal hypoglycemia		at delivery	No
Secondary	jaundice requiring phototherapy		within the first 2 weeks after delivery	No
Secondary	lipid profile		56 days- 8 weeks	No
Secondary	insulin therapy requirements		56 days- 8 weeks	No