Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2016-08-31
2019-05-31
Brief Summary
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Detailed Description
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Several lines of evidence indicate that endothelial dysfunction is a central feature of the pathophysiology of preeclampsia. Asymmetric dimethylarginine (ADMA) is a methylated metabolite of the amino acid L-arginine and an endogenous inhibitor of nitric oxide synthase (NOS). High concentrations of ADMA contribute to endothelial dysfunction and ADMA inhibits angiogenesis and arteriogenesis, activities important in pregnancy and deficient in preeclampsia. ADMA concentrations are higher early in pregnancy among women who later develop preeclampsia. This protocol describes a randomized placebo-controlled trial of L-citrulline in 40 pregnant women with type 2 diabetes from approximately sixteen to nineteen weeks gestation, to determine whether L-citrulline supplementation increases the plasma L-arginine/ADMA ratio, lowers maternal blood pressure and increases a circulating marker of placental function (placental growth factor PLGF).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Citrulline
Oral L-citrulline, 3 grams once per day for 3 weeks.
L-Citrulline
amino acid supplement
Placebo
Placebo, 3 grams once per day for 3 weeks.
Placebo
placebo
Interventions
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L-Citrulline
amino acid supplement
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes with hemoglobin A1c \<8
* Gestational age at randomization between 14 and 16 weeks based on clinical information
* Maternal age between 14 and 40 years
Exclusion Criteria
* Major fetal anomaly
* Fetal demise
* Planned termination of the pregnancy
* Collagen vascular disease (autoimmune disease) on medication
* Renal disease
* Epilepsy or other seizure disorder
* Active or chronic liver disease
* Heart disease, known illicit drug or alcohol abuse during current pregnancy
* Already taking L-citrulline as a supplement (1gram/day or more)
14 Years
40 Years
FEMALE
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Robert Powers
Associate Professor
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO15090627
Identifier Type: -
Identifier Source: org_study_id
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