Inositol Stereoisomers to Treat Gestational Diabetes
Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedMarch 26, 2014
March 1, 2014
1 year
February 27, 2014
March 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)
56 days- 8 weeks
Secondary Outcomes (7)
hypertensive disorders
56 days- 8 weeks
macrosomia
at delivery
cesarean section
at delivery
neonatal hypoglycemia
at delivery
jaundice requiring phototherapy
within the first 2 weeks after delivery
- +2 more secondary outcomes
Study Arms (4)
Subgroup A
OTHERfolic acid 400 mcg/day
Subgroup B
EXPERIMENTALmyo-inositol 2000 mg twice a day
Subgroup C
EXPERIMENTALD-chiro-inositol 250 mg twice a day
Subgroup D
EXPERIMENTALMyo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
Interventions
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
Eligibility Criteria
You may qualify if:
- Gestational Diabetes diagnosed within 24-28 weeks gestation
- Caucasian pregnant women
You may not qualify if:
- Pre-pregnancy diabetes
- Non-singleton pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital "SS Annunziata"
Chieti, Chieti, 66100, Italy
Related Publications (7)
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. No abstract available.
PMID: 9704245BACKGROUNDCasey 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. doi: 10.1016/s0029-7844(97)00542-5.
PMID: 9397092BACKGROUNDJovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. doi: 10.1001/jama.286.20.2516. No abstract available.
PMID: 11722247BACKGROUNDNestler 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. doi: 10.1056/NEJM199904293401703.
PMID: 10219066BACKGROUNDCroze 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.
PMID: 23764390BACKGROUNDCorrado 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: 21414183BACKGROUNDFraticelli F, Celentano C, Zecca IA, Di Vieste G, Pintaudi B, Liberati M, Franzago M, Di Nicola M, Vitacolonna E. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol. 2018 Aug;55(8):805-812. doi: 10.1007/s00592-018-1157-4. Epub 2018 May 17.
PMID: 29774465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Ester Vitacolonna
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 26, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Last Updated
March 26, 2014
Record last verified: 2014-03